Methods for transtendinous implantation of knotless micro suture anchors and anchor arrays

ABSTRACT

A method and apparatus are provided for transtendinous implantation of a toggle-type bone anchor. Measured from the top surface of the tendon, the entire bone anchor is inserted to a depth of greater than or equal to 20 mm. during a rotator cuff repair on the humeral head. The anchor is pushed by the same bone punch that formed the initial hole to assure proper depth of placement. Further, the apparatus includes a nub portion that, in use, protrudes into the bone hole formed by the bone punch and maintains registration with the bone hole when the bone punch is retracted. An angled distal end on the anchor initiates toggling during insertion into the bone and at least one proximal projecting fin prevents the anchor from backing out of the bone hole while facilitating further rotation of the anchor when a suture is pulled to complete toggling.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of and priority to US Prov.Pat. App. No. 63/172,630, filed Apr. 8, 2021, titled METHODS FORTRANSTENDINOUS IMPLANTATION OF KNOTLESS MICRO SUTURE ANCHORS AND ANCHORARRAYS, and U.S. Prov. Pat. App. No. 63/281,411, filed Nov. 19, 2021,titled DELIVERY DEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS ANDANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TO BONE, the disclosures ofwhich are incorporated herein by reference.

BACKGROUND

Throughout the human body there are many attachments of soft tissue,such as tendons and ligaments, to bone as integral elements of motion infunctioning joints such as the shoulder. The shoulder joint includes thehumeral head of the upper arm bone in contact with the indentation ofthe glenoid working in conjunction with the rotator cuff, which is acombination of muscles and tendons forming a capsule that bothstabilizes the joint and causes desired motion. Injury to the connectionbetween tendons of the rotator cuff muscles to the humeral head, usuallya tear in a tendon, is common. These tears do not self-heal. It isestimated that in the U.S. over 4 million people annually are referredto a surgeon due to shoulder pain and over 500,000 of these referralsresult in shoulder surgery to repair the rotator cuff.

Significant effort has been expended over the past 30 years to developbone and tissue anchor devices and methods to respond to the need foreffective rotator cuff repair. Early methods and devices utilized anopen surgical technique that required a large incision of 4 to 6 cm andcutting the deltoid muscle, then re-attaching after the rotator cuffrepair. This method is still used today for massive tears by somesurgeons due to high success rate, however, the procedure is associatedwith deltoid dysfunction, significant pain during recovery and extensiverehabilitation time. Due to the invasiveness of the open surgery andresulting rehabilitation time, a “mini-open” procedure and associateddevices were developed in the early 1990's, wherein the surgeon usespartial arthroscopic techniques followed by an incision and split of thedeltoid muscle fibers to access the rotator cuff tendon for repair. Bythe late 1990's, devices and instruments were further developed tocomplete the repair of rotator cuff tendon attachment to bone usingall-arthroscopic techniques, with further resultant reduction in traumaand recovery time.

Arthroscopic repair of the rotator cuff tendon attachments to thehumeral head are the most common technique used today. However, it isrecognized that these all-arthroscopic techniques are quite difficult toperform and achieve varying results. The skill of the surgeon with thetechnology available is a known factor related to the procedure'ssuccess. Even with the last 20 years of all-arthroscopic technologicadvancement and experience, deficiencies persist as evidenced by studiesindicating an overall average rotator cuff repair failure rate of 20% to40%, with a highly variable range of 4% to 90% in individual studies.The study results indicate failure rates are much higher for large ormassive tendon tears and there are vast variations in failure ratesbetween surgeons, as well as with respect to various patient factors,equipment used, and type of repair completed.

There is significant controversy among professionals as to the reasonsfor the high incidence of arthroscopic rotator cuff repair failure (i.e.“re-tear of the rotator cuff”). However, studies clearly show there is aneed to reduce the failure rate of arthroscopic rotator cuff repair toavoid its effects of patients' lack of mobility, functional deficits,increased pain and/or requiring subsequent and more invasive surgerywith the attendant pain and rehabilitation. In particular, there isgreat concern for patients who have some degree of native tendon orrepair tendon failure yet choose to “live with it” rather than goingthrough a first or additional surgery and rehabilitation, thus affectingquality of life and promoting continued joint degradation from lack ofuse.

The basic device or devices used for repair of a tendon torn from a boneis one or more suture anchors in which a mechanical structure providesan anchor to the bone and a suture or sutures extend therefrom forattachment to the soft tissue or tendon. Many types of anchortechnologies have been proposed and used in procedures. A review of theprior art patent literature indicates over a thousand designs for sutureanchors, bone anchors, tendon repair systems, delivery devices andmethods espousing improved features over the past 25 years, yet repairfailure rate is still unacceptable indicating the need for furtherimprovement in the area of arthroscopic reattachment of tendons to boneand in particular in rotator cuff repair.

Overview

The present inventors have recognized, among other things, that aproblem to be solved is the need for new and/or alternative devices andmethods for arthroscopically affixing a tendon or other soft tissue tobone, such as in rotator cuff repair, with low failure rate, preferablyunder 10% on average, with little variation between surgeons, patientcharacteristics, and the system/method used for repair. The discloseddevices, systems, and methods, along with a statement of the problembeing solved by each element are included in summary form followed by adescription of specific claimed structure or methods in the presentdisclosure.

The present disclosure includes a total system for re-attaching a tendonthat has at least in part torn away from a bone attachment or footprint.The system is useful in repair of a rotator cuff tendon that has tornaway from a bone but can be used in other soft tissue and tendon repairprocedures. The system is particularly useful in repair of the rotatorcuff by reattaching a torn tendon, such as the most-commonly-tornsupraspinatus tendon, to the humeral head of the arm. In larger tears,the infraspinatus tendon may also be torn and amenable to repair withthis system. The repair is an anatomical repair, meaning that thesystem, devices and methods result in a repaired tendon and bonecombination that closely approximates the prior natural, anatomicrelationship between that tendon and bone to promote healing and providepain-free full function to the healed repair. An anatomical repair usingthe presently described system may also seal the tendon in position,taking advantage of local synovial fluid to aid healing and improvepost-surgery function. The system may also be used to reinforce partialtears and to secure areas beyond the region of a full-thickness tear asneeded. Further, the system, as implanted can dramatically reducerecovery and rehabilitation time due to the robust nature of the repairimmediately following surgery, requiring less time using a sling tolimit mobility and allowing early physical therapy to maintainpre-surgery mobility and strength during healing. It is believed time ina sling and complete recovery time can be reduced at least 50%, whilereducing the average failure rate to less than 10% with the currentdisclosed system.

As stated, in preferred examples, the exemplary rotator cuff repair isan anatomical repair in that the repaired tendon nearly duplicates orclosely approximates the natural tendon and bone relationship in thefully functional joint. For example, the tendon/tendons is/aresubstantially and completely re-attached to the original footprint onthe bone from which it was torn. The original footprint area providesthe greatest likelihood of healing re-attachment of the tendon to thebone while restoring anatomy. By substantially re-attached to theoriginal footprint it is meant that a substantial portion of theremaining torn tendon surface that was originally attached to thefootprint is re-attached thereto. The current system makes possibleclose approximation of the original tendon attachment by allowingtranstendinous or through the tendon implantation of each anchor. Thus,the tendon is held in the desired location when the anchor is installed,unlike current systems that insert anchors into exposed bone through atear and then use suture passers (which pass the suture when the tendonis not in position) to approximate where the surgeon believes the tendonwill pull down to the footprint. Further, the anatomical repair reducesmicromotion at the bone to tendon interface so that healing is promoted,even during movement of the joint. Finally, access to blood for healingis improved due to utilizing substantially more small holes in theproximal humerus that are not occluded by the implant sutures toaccommodate a large number of anchors in a close or high-density array.

In fresh cadaveric studies using the presently disclosed system, therepaired tendon and bone combination provides a tensile strength uponre-attachment of greater than 400 Newtons (N) and initial cyclic creepor gap formation of less than 2 millimeters (mm) when cycled to a peakload on the repaired tendon per cycle of 180 N. Initial cyclic creepmeasures the rigidity or robustness of the attachment of the tendon tothe bone as it measures how much the tendon slides or moves relative tothe bone attachment. Low initial cyclic creep allows the potential forfaster healing and less need for sling immobilization. Creep of lessthan 2 mm, or even less than 1 mm, is therefore a preferred outcome insome examples. In other words, if the tendon stays fixed in positionrelative to the bone it is compressed against (i.e. reducedmicromotion), the healing process will occur more quickly andpredictably than a situation that includes sliding of the tendon backand forth relative to the bone.

In selected embodiments, the anatomic repair requires a high-densityarray of knotless small anchors (requiring a bone hole size forinsertion of less than 3 mm) with close spacing between anchors (lessthan 7 mm edge to edge, or less than 10 mm hole center to hole center)to create anchor to subsequent anchor or serial anchor suture stitchesthat apply many points of constant independent force on the tendonagainst the bone. By independent it is meant that failure of one suturestitch to apply adequate force, as would happen if the suture stitchbroke, does not affect other suture stitches. Naturally, the number ofanchors utilized in a repair will depend upon the size of the tear.

It is recognized in the art that rotator cuff tears are classified intofour categories based on tear size and whether a single row or doublerow repair is completed. Small tears are less than 1 centimeter (cm) inlength; medium tears are 1 cm to 3 cm in length; large tears are 3 cm to5 cm in length and massive tears are greater than 5 cm in length. Withcurrent devices, surgeons are limited to available large anchors and bythe size of the tear as the medial anchors must fit in the tear areathat exposes bone. For example, surgeons may use about 1 medial anchoron small tears, 1 or 2 medial anchors on medium tears and 2 or 3 medialanchors on large tears and massive tears. With the high anchor densityanatomical repair of the present application, the surgeon is not limitedby tear size as the anchors are implanted through the tendon and can usegreater than 3 medial anchors on small tears, greater than 5 medialanchors on medium tears, and greater than 6 medial anchors on largetears and massive tears. This can include positioning implants outsidethe area of a full thickness tear to reinforce areas of partialthickness tears or weaker untorn tendon. Further, the present sutureanchors are designed for knotless tensioning and locking to expediteimplantation, maximize reproducibility amongst surgeons, and notinterfere with shoulder mobility from protruding knots while eliminatingthe tension variations that have been found in knotted suture anchorsdue to the difficulty of tying knots arthroscopically.

The suture anchors of the present disclosure are bar or toggle typeanchors wherein the basic structure for bone attachment is a thinelongate and/or cylindrical body having a cross sectional diameter ofless than about 3 mm and a length of about 6 mm to about 10 mm.Alternative sizes could be used in other applications in the body asdesired. Although described as generally cylindrical, it is recognizedthat certain surfaces can be machined or molded flat or grooved to allowfor suture strands to run alongside the implant when placed in acircular delivery tube. That is, rather than cylindrical, the presentanchors may be polygonal, for example, hexagonal or octagonal, or othercross-sectional shape. The anchor is a through the tendon ortranstendinous implant as described with respect to the delivery deviceand method below. Being transtendinous eliminates the requirement ofplacing the anchors only where the tendon is absent from the bone suchas in the hole formed by the tear or outside the tendon footprint.Furthermore, and importantly, the need for suture passing through thetendon is eliminated.

Transtendinous implantation with anchors used today entails technicalchallenges, including working a 3 mm to 6 mm diameter anchor through ahole created in the tendon with an awl, damaging the tendon. Further,threaded and flanged type anchor retention features of known, largeranchors, would damage the tendon during passing.

With a toggle type anchor, the anchor is inserted through a hole in thebone just larger than the anchor axial outer diameter. Within the bone,the anchor is toggled (aka flipped or rotated) about 90 degrees, but atleast 60 degrees so that force applied to sutures extending from thetoggle body pull the length of the toggle body against the inner surfaceor underside of the cortical shell of the humeral head. The degree towhich the toggle body rotates or moves toward the cortical shell isaffected by the quality of the bone and by individual patient traits,such as age, sex, location of the hole in the bone and degree of bonedegradation due to the tear. The toggle body of the current invention isdesigned to toggle and seat with adequate pullout strength over therange of bone qualities encountered.

The toggle body functions in conjunction with a single suture line,referred to herein as the working suture which passes through at leastone passage formed through the toggle body. The number of passages canbe varied in the design of the toggle body as can the way in which theworking suture is threaded through the passages to provide desiredtensioning and locking functions. In some embodiments the toggle bodyincludes three holes passing through the toggle body generallyperpendicular to the longitudinal axis. In this embodiment the workingsuture passes through the top and out the bottom of a proximal hole,then back up through the bottom of a distal hole and out the top. Theworking suture is flossable or slidable as positioned through the twoholes by pulling with sufficient force on either working suture legextending out the top of the toggle body. On the bottom surface of thetoggle body, a length of working suture extends longitudinally past themiddle hole. A suture lock, which includes a separate piece of suture orthread or other flexible cord extends through the center hole, with anadjustable or collapsible loop or slidable knot which allows the loop tobe contracted, extending around the perimeter of a portion of theworking suture as it passes the middle hole. The other end of the suturelock cord extends from the top of the center hole. When the top end orproximal end of the suture lock is pulled, the adjustable loop collapsestight against the working suture and can pull at least a portion of theworking suture into the center hole to create a lock on the workingsuture so that it can no longer slide and will not slide under full loadas implanted. In some embodiments, the tightening of the suture lockpulls a small portion of the working suture into a slot or channel inthe bottom of the middle hole in the anchor. The working suture ispinched in a tortuous path that provides a sound lock and preventssliding of the working suture relative to the anchor once the suture isappropriately tensioned. The strength of the lock is enhanced by theoverall tortuous path followed by the working suture when the anchor ispulled against the cortical shell as the working suture goes throughseveral near 90-degree turns which provide increased friction againstthe toggle body as well as the friction applied by the suture lock.

Each individual anchor includes features that assure it will implantproperly through the tendon in a hole punched through the cortical shellof the humeral head. The anchor is inserted lengthwise through this holeinto the spongy or cancellous bone. It is pushed by the point of a bonepunch that mates with a dimple formed in the proximal end of theimplant. The mating surface dimple is shaped to help maintain contactbetween the anchor and the punch while also allowing the anchor topivot, rotate, or toggle from an insertion configuration in which thecentral axis of the anchor is aligned with the central axis of the punchto an implant configuration in which the central axis of the anchor nolonger aligns with the central axis of the punch. The rotation ortoggling may have two parts: an initial change of axial direction as theanchor passes beyond the cortical shell into the cancellous bone duringadvancement as the punch is used to push the anchor, and a second changeof axial direction under tension applied using the working suture asdescribed below. The cancellous bone varies greatly in properties bylocation and patient ranging from very soft and porous to hard cellularstructures depending upon many patient-specific factors. The includedfeatures of the present anchor assure proper toggled retention withinthe bone over the range of cortical shell and cancellous bonevariations.

In selected embodiments, the implant preferably includes an acute angleon the distal surface with the upper side projecting furtherlongitudinally than the lower side. Inserted this way, the longerportion engages the cancellous bone and begins rotation during anchorinsertion. With both the distal and proximal portion of the workingsuture extending up through the bone hole, one can pull the distalworking suture selectively, which further rotates the implant body. Insome examples the rotation may be to an angle of about 90 degreesrelative to the central axis of the bone hole, though this extent ofrotation is not necessary to the inventive concept. It has been foundthat in hard cancellous bone, the pulling on the distal suture at timesmay not cause rotation because the proximal portion is held rigid by ahard layer of cancellous bone and therefore pulling causes the togglebody to back out of the hole and lie under the tendon. To prevent this,the implant includes a fin or fins on the proximal portion that upondelivery project proximally and radially with a cross dimension greaterthan that of the bone hole. The size of the fins prevents back out ofthe anchor but also the fins are located to project and to catch on thecancellous bone and assist in rotation. The fins alone may notaccommodate the full pullout force in some examples, rather the toggleanchor must rotate as well so that the force pulling on the anchor iscarried by the side wall of the toggle body as rotated.

The single working suture is pre-strung through a plurality of anchorsto be used as a set to form an implanted array having a tensioned suturestitch extending from one anchor to the subsequent anchor in thepre-strung chain. As previously stated, each anchor is slidable orflossable with sufficient force applied to move along the workingsuture. Each anchor is equipped with a suture lock as described above,except the first anchor in the chain which can have a standard suturelock or a fixed non-slidable suture connection. A chain of anchors cancarry in the range of about 8 to 12 anchors in some preferredembodiments.

The high-density array of anchors is formed by implantation of theanchors in a chain or row which can be a relatively straight line orcurve depending upon the tear to be repaired at the discretion of thesurgeon. A delivery device system designed for sequential transtendinousimplantation of each anchor in the array is disclosed herein thatincludes three main components or assemblies: a delivery device thatincludes multi-function trigger and linkage features; a plurality ofcartridges with each cartridge retaining a suture anchor with theworking suturing running sequentially from cartridge to next cartridge;and, a magazine that is releasably mountable on the delivery device andhold the cartridges in order for sequential use.

The delivery device can be a gun-like component that has a body portionthat includes a pistol grip type handle and trigger mechanism that movesfrom a spring retained released position to an engaged position uponsqueezing and holding the trigger. The trigger mechanism is linked tomoveable internal features within the gun-like component to providedesired functions during implantation described below. The gun-likecomponent also includes a barrel assembly or elongate tube extendingdistally from the gun-like component housing that includes alongitudinal slotted lumen over its length for receiving suturestherethrough. The component housing includes a lumen extending thelength of the housing that is aligned with the lumen of the elongatetube which together create a full-length lumen running from the proximalend to the distal end of the delivery device and can receive full lengthpunch pinch slidably therein. The elongated tube also includes an anchordelivery tube disposed in the lumen that aligns with the housing lumenfor receiving the punch pin therethrough. The anchor delivery tube alsohas a longitudinal slot aligned with the longitudinal slot of theelongate tube for passing a suture therethrough. The anchor deliverytube lumen can have a round cross section or alternatively a lengthwisevanishing lower channel that allows suture material to slide thereinwithout binding. The anchor delivery tube is slidable within the lumenof the elongate tube lumen between an extended position in which a nubof the anchor delivery tube extends distally of the end of the elongatetube to a retracted position in which the distal end of the anchordelivery tube is about even with the distal end of the elongate tube.The proximal end of the anchor delivery tube terminates within thehousing and is adjoined to a nub sub coupler member that is slidablewithin a portion of the housing to allow for the two positions of theanchor delivery tube. The nub sub coupler can selectively be engagedwith the trigger mechanism so that pulling the trigger actively retractsthe nub when desired.

When the nub is in the distally extended position, the proximal end ofthe anchor delivery tube is aligned longitudinally with a chamber in thetop of the housing for receiving a cartridge carrying an implanttherein. A plunger assembly can then be engaged to push the carriedanchor laterally into alignment with the proximal end of the lumen inthe anchor delivery tube in a position ready for delivery down thelumen. A punch pin assembly is used to push the anchor distally.

The punch pin assembly includes an elongate punch pin slidably disposedin the lumen extending the length of the delivery device with a punchhead assembly projecting from the proximal end of the housing tomanipulate the punch position. The distal end of the punch pin includesa tapered point for both creating a bone hole and for engaging theproximal end of an anchor to deliver it. The punch head assembly caninclude both a distal punch head and a proximal punch head. The punchpin is affixed to the proximal punch head which provides a surface fortapping the punch pin into bone or pushing an anchor in the lumen. Thepunch pin is slidable within the distal punch head and the distal punchhead snap latches to the housing of the delivery device. The proximalpunch head and distal punch head are connected by a spring-loadedmechanism that holds the punch pin in a fully extended position when theproximal punch head is pushed against the distal punch head and latched.This motion also pushes the nub distally of the elongate tube. When theproximal punch head is released from close connection with the distalpunch head, the spring causes the punch pin to withdraw proximally to apartially retracted position with only a short distal portion of thepunch pin extending beyond the elongate tube for use in probing apotential implant site. To aid pin retraction, the trigger may be(indirectly) coupled to the punch pin to provide positive retractionforce when the trigger is actuated.

The operation of the delivery device with the housing and triggermechanism, the fixed elongate tube and slidable anchor delivery tube,the plunger assembly and the punch pin distal end and two-part punchhead are best understood with description of the implant procedure usedin implanting an anchor of the disclosed array. In a preferred method,the punch pin is set in the partially extended position with the distalpunch head snap latched to the proximal end of the housing and theproximal punch head released from the distal punch head so it is spacedproximally by the spring and held in position. The nub is also in acompletely retracted position and the plunger is disengaged. With thisarrangement the surgeon can insert the delivery device distal end into aport at a treatment site and use the distal tip of the punch to probethe tendon and bone to locate both a location and angle at which tocreate an anchor hole through the tendon and into the bone beneath.

Once the implant site is found, the surgeon can push, tap or pound onthe proximal end of the proximal punch head which will drive theproximal punch head distally into connected engagement with distal punchhead. This movement causes the punch pin to extend fully from the distalend of the delivery tube while at the same time pushing the nub toextend distally from the distal end of the delivery tube. Continuedtapping on the proximal punch head causes the punch pin and nub topenetrate tendon, then bone to create an implant hole with at least aportion of the nub extending into the bone. The assembly isadvanced/inserted until the distal end of the elongate tube is indesired contact with the tendon surface. At this point the trigger ispulled, and the trigger movement forces an ejector to engage the punchpin to unlatch the distal punch head from the proximal housing, and theproximal punch head from the distal punch head, which automaticallypulls the entire punch pin proximally. Because the plunger is notengaged at this time, the nub remains locked in place, fully extendedfrom the distal end of the elongate tube. The punch is withdrawnproximally while the nub remains locked in place and maintainsregistration with the formed hole and the elongate tube is pressedagainst the tendon surface. A first anchor is loaded into the elongatetube proximal portion within the anchor delivery tube and the punch isagain moved distally to force the first anchor/implant down the anchordelivery tube through the tendon via the nub and into the bone. The nubfunctions like a shoehorn to track the anchor through the spongy tissueof the tendon that has likely closed around the nub.

To load the anchor into the delivery tube adjacent its proximal end, acartridge containing one anchor in the serial array is loaded into thechamber on top of the delivery device. The plunger is then pushed in andlatched in position, which causes the anchor to move laterally intoalignment with the distal tip of the punch pin. With the plungerlatched, the distal end of the plunger holds the anchor in position forpushing engagement so that the distal tip of the punch pin engages thedimple on the proximal end of the anchor. Importantly, the pushing in ofthe plunger also changes the function of the trigger linkage. A lowerbeam on the plunger assembly pushes a slide stop into a second positionthat unlocks and allows retraction of the nub and further releases aprojection that holds an ejector in an unlatched configuration whileactively pushing that same ejector upward on a ramp to engage a nub subcoupler on the proximal end of the anchor delivery tube. With thesechanges, squeezing the trigger after the anchor is implanted and withthe plunger latched not only causes the release of the punch assemblybut also actively retracts the nub out of the bone hole and into theelongate tube. This can be important as the implanted anchor must bepulled to toggle against the inner bone surfaces and the presence of thenub can interfere with such motion or damage the working suture of thearray. As the nub retracts under spring pressure and with active forceapplied as the trigger is squeezed, the ejector causes disengagement ofthe plunger latch as well, resetting the delivery device for use with asubsequent anchor.

The anchor, once loaded into the anchor delivery tube by the plunger, isarranged with the distal suture hole having a distal portion of theworking suture extending therefrom. After insertion into the bone hole,and with the punch pin and nub retracted, the distal portion of theworking suture is pulled to further rotate the toggle body and move ittoward the cortical shell. On this first anchor only, the working suturemay be locked into position using the locking suture prior to pullingthe distal suture, or even prior to starting implant of the firstanchor, if desired, as no stitch type bridge can be formed until asecond anchor is implanted. In some examples, the first anchor may beaffixed to the working suture, and the locking suture may be omitted forthe first anchor. When the first anchor is set in sufficiently strongmaterial inside the bone (which can be harder cancellous bone or may beresting against the under surface of the cortical shell) the deliverydevice can be set with the punch pin partially extended as it was at thebeginning of the procedure and moved for implantation of the nextanchor. The empty cartridge is also removed.

With the second and subsequent anchors, both a proximal and a distalsuture portions of the working suture extend up through the deliverydevice. It is the distal portion of the working suture that is pulled tocause rotation of the anchor while also allowing the working suture toslide through both holes in that anchor and the slack extending to thedistal hole of the previous anchor is therefore shortened. It is alsorecognized that the proximal portion of the working suture can betensioned in some embodiments to aid in rotating and seating the anchorin proper position within the bone hole. This is continued until theproperly tensioned suture stitch is formed at which point the suturelock on the second or subsequent anchor is activated to maintain tensionin the individual suture stitch. The locking suture proximal extensioncan be cut off after tightening or a selectively breakable suture can beused and such breakable portion is positioned proximate the slidableknot.

This is repeated for a desired number of anchors in the pre-strung chainwhich as implanted to form a high-density array as described above. Ascan be understood, the number of suture stitches formed is equal to thenumber of anchors in the chain implanted minus 1. Further, the string ofstitches is serially continuous with each stitch tensioned and lockedindependently to form a required robust tendon attachment. Thecontinuous string of stitches can form a row or chain of stitches ofdesired shape such as a linear row, a zig-zag shape, an arc, etc. By rowor chain, it is meant that the suture stitches extend from one anchor tothe next in the sequence of implanted anchors. It is understood thatmore than one continuous string of stitches can be formed by implantingmultiple anchor arrays that together form an overall repair array,especially for large tears.

As previously stated, the distance between ends of a suture stitch (thedistance between anchors) is preferably less than about 7 mm (less thanabout 10 mm from center of hole to center of hole) to provide consistentforce on the tendon against the bone to reduce creep. One particularlyrobust array of implanted anchors includes a first array implanted in amedial portion of the original tendon footprint to form a row or line ofstitches generally perpendicular to the length or direction of thetendon's forces. A second array can then be implanted laterally nearerthe edge of the tear with at least one anchor through the tendon whileat least one other anchor is implanted laterally of the tendon edge toreapproximate the tendon properly against the bone. The lateral row canbe implanted in a zig zag pattern or other appropriate pattern based onthe shape of the tear. Depending upon tear size and location, multiplepatterns can be utilized.

As becomes clear in the above description, the pre-strung array ofanchors in combination with the working suture and multiple lockingsutures creates a strong need for a delivery system that has componentsthat manage the anchors and their attendant sutures or suture sectionsto maintain orderly implantation, use and sterility during a procedure.Further, the small size of the anchors necessitates some sort of holderor cartridge for individual anchors. Applicants disclose herein anattachable magazine and multi-cartridge assembly that integrates withthe above-described delivery device. The assembly includes a cartridgefor each anchor in a given array with the individual cartridges storedand managed in a cartridge magazine in a way that maintains theintegrity of the array and allows the surgeon to access and use eachanchor in the array sequentially.

Within each cartridge the anchor is releasably held in a fixed positionwith proximal and distal working suture portions running through theanchor plus the suture lock being pre-strung on the anchor (it may benoted that the first cartridge/anchor may omit the suture lock and/orhave a single portion of working suture extending therefrom). The endsof the proximal and distal working suture portions pass to the next orprior cartridge as appropriate. The length of proximal suture lockmaterial is preferably stacked or coiled within the holder, such as on apulley, with a proximal end attached to the pulley or cartridge.Further, the internal structure of the cartridge includes at least oneboss that the suture goes around to keep the suture more easilyflossable through the anchor so that one grasping the cartridge can movethe anchor and cartridge assembly to a desired location on the workingsuture before implantation. In one preferred design, the cartridgeincludes an anchor retention door that is closed during handling andstorage while having feature that prevent the anchor from being removedfrom the cartridge. When the anchor cartridge is inserted in the chamberof the delivery device, the anchor retention door is opened and allowsthe plunger distal end to engage the anchor and slide is laterally intoalignment with the lumen of the barrel.

The entire array of anchors as mounted in individual cartridges isstored in a magazine that stacks the cartridges in sequential order foruse by the surgeon. The stack is preferably held by a spring-loadedmember with the removal station at the opposite end of the magazine. Theremoval station can include a tabbed tipping structure or cartridgeejector that tips the anchor forward relative to the remaining stack foreasy grasping when ready to use. Further the cartridge ejector canretain the subsequent anchors firmly so that the taken anchor can beflossed to an appropriate position on the working suture tail thatextends both directions from the anchor.

The overall design of the anchor may include the following features. Theanchor may include a distal end having an angled leading surface toencourage the anchor to begin to toggle as it exits the anchor deliverytube and nub. The anchor has a bottom side and a top side, with thebottom side being shorter than the top side due to the angled leadingsurface. The anchor may include a proximal end having a pair of fins oneither side of a depression or dimple to receive the distal tip of thebone punch during insertion, where the dimple loosely receives thedistal tip of the bone punch to allow the anchor to begin to toggle asit exits the anchor delivery tube and nub. The fins are adapted to becompressed while in the anchor delivery tube and to then open up afterexiting the anchor delivery tube to discourage backing out of the anchoras it is toggled into its final position. The anchor also includesproximal and distal holes for passing the working suture therethrough,and a middle hole that allows a locking loop or cord to passtherethrough. The middle hole may include a platform that provides asurface against which the locking loop can be compressed when the freeend of the locking loop is tensioned, allowing the locking loop totighten onto and affix the working suture.

A pre-strung anchor may then be configured with the working suturepassing into the proximal hole from the top of the anchor, out of thebottom side and then along the bottom side of the anchor to the distalhole. The working suture may extend up through the distal hole and exitsat the top side. A locking loop extends out of the middle hole andsurrounds the working suture. A pre-strung array of anchors may includea plurality of anchors disposed along a single working suture, with eachanchor having its own locking loop. Alternatively, a pre-string array ofanchors may include a first anchor that is permanently affixed to thesingle working suture, and a plurality of additional anchors eachdisposed along the single working suture and each having its own lockingloop. Each locking loop may include a free end that can be tensioned tolock the working suture of an anchor to the anchor once implanted andtensioned.

The overall design of the anchor delivery tool may include the followingfeatures. The anchor delivery tool includes cartridges and a magazine tosimplify the steps performed the implanting surgeon, who does not haveto handle the individual anchors directly. The individual cartridges andmagazine may hold each of the anchors, corresponding locking loops, andthe working suture to keep each out of the surgeon's way during arrayimplantation. The anchor delivery tool guides the bone punch for thephysician and allows pounding of the bone punch to create a bone hole.After bone hole formation, the anchor delivery tool nub maintains thepath into the bone hole that is formed by the bone punch, and allows useof the same path for both the bone punch and the anchor. The anchordelivery tool allows the same tool to be used for both hole formationand anchor advancement, and repeatably aligns the implantable anchorscorrectly for implantation into the formed bone hole. The anchordelivery tool includes a trigger system that performs first and secondretraction functions, simplifying the implant procedure as the firstactuation of the trigger releases the bone punch but holds the nub inplace and the second actuation of the trigger releases the nub. Thefirst and second retraction functions as described are differentiated,from the perspective of the delivery tool, by the use of the plunger.The anchor delivery tool may automatically reset itself after the secondactuation of the trigger to allow repeated anchor delivery. The anchordelivery tool may include features for suture management. While thesefeatures may make the disclosed anchor delivery tool advantageous foruse in implanting an anchor or array of anchors, the anchors and arraysof anchors disclosed are not necessarily limited to use with such adelivery tool.

Following are a number of illustrative and non-limiting examples. Thespecific features identified in these examples may be studies inconjunction with the overall system and may be further understood byreference to the following detailed description and attached Figures.

A first illustrative and non-limiting example takes the form of a methodfor transtendinous implantation of a toggle-type suture anchor in bone,the method comprising the steps of: positioning a delivery devicerelative to a tendon, the tendon being located at a desired location forsecuring to bone, the delivery device including an anchor delivery tubehaving a lumen therethrough, the anchor delivery tube having a nubportion at a distal end thereof, wherein a bone punch assembly extendsthrough the lumen of the anchor delivery tube and the nub portion with apointed distal end terminating a distance distal of the distal end ofthe nub portion; placing the delivery device and bone punch assembly ata desired location on the tendon and pounding the bone punch through thetendon into the bone a desired depth, at least passing through acortical shell of the bone, wherein the nub portion advances through thetendon and into the bone as the bone punch is pounded through the tendonand into the bone; retracting the bone punch assembly while maintainingthe nub portion in registration with the formed hole in the bone andthrough the tendon; inserting a toggle-type suture anchor in theproximal portion of the anchor delivery tube, the toggle-type sutureanchor having a generally elongate body having a length of sutureextending through the elongate body from a top surface to a bottomsurface thereof; re-inserting the bone punch assembly into the lumen ofthe anchor delivery tube and thereby pushing the toggle-type sutureanchor into the bone beyond the cortical shell; retracting the bonepunch and nub at least into the delivery device; and pulling the sutureto complete toggling of the toggle-type suture anchor toward the insidesurface of the cortical shell of the bone.

Additionally or alternatively, the delivery device further comprises anouter tube surrounding the anchor delivery tube over its length, whereinthe anchor delivery tube is moveable relative to the anchor deliverytube; and the step of pulling the suture is performed with the outertube pressed against the tendon at the desired location and with the nubretracted into the outer tube.

Additionally or alternatively, the delivery device comprises a proximalhousing having a trigger thereon, and the step of retracting the bonepunch and nub portion at least into the delivery device is performed bydepressing a trigger to apply an active force to retract each of thebone punch and the anchor delivery tube and nub portion.

Additionally or alternatively, the bone punch is inserted into the boneto a depth where a distal end of the outer tube is in contact with thetendon surface. Additionally or alternatively, the delivery device isconfigured such that, when the bone punch is advanced to a maximumextent relative to the outer tube distal end, the bone punch extendsbeyond the outer tube distal end a distance of greater than or equal toabout 20 mm. Additionally or alternatively, the anchor delivery tube isconfigured such that, when the nub portion is advanced to a maximumextent relative to the outer tube distal end, the nub portion extendsbeyond the outer tube distal end a distance of about 6 to about 10 mm.

Additionally or alternatively, the toggle-type suture anchor has aproximal end having a dimple configured to receive the bone punch and anangled distal end which, during the step of pushing the toggle typesuture anchor into the bone, enters the bone first, wherein the angleddistal end initiates toggling of the toggle-type suture anchor.

Additionally or alternatively, the toggle-type suture anchor comprisesproximal and distal suture passing bores with the suture passing througheach of the proximal and distal suture passing bores, and during thestep of pulling the suture, a portion of the suture projecting from thedistal suture passing bore is tensioned to toggle and position thetoggle-type suture anchor.

Additionally or alternatively, the delivery device further comprises aslot and a plunger; and the step of inserting a toggle-type sutureanchor in the proximal portion of the anchor delivery tube comprises:placing a cartridge carrying the toggle-type suture anchor in the slot;and depressing the plunger to move the toggle-type suture anchor fromthe cartridge to a position in alignment with a central axis of theanchor delivery tube lumen.

Another illustrative and non-limiting example takes the form of a methodfor transtendinous implantation of a toggle-type suture anchor in bone,the method comprising the steps of: positioning a delivery device over atendon and bone, the delivery device including a handle assembly havingan outer tube affixed thereto and extending distally therefrom with alumen therethrough, further with an anchor delivery tube extendingthrough the lumen of the outer tube having a proximal end affixed to thehandle assembly, the anchor delivery tube having a nub portion at adistal end thereof, wherein the anchor delivery tube is extendible andretractable relative to the outer tube to allow the nub portion toextend and retract relative to the distal end of the outer tube, havinga bone punch assembly extending through the lumen of the anchor deliverytube and the nub portion with a pointed distal end and a proximal endextending past the handle assembly of the delivery device; placing thedistal end of the bone punch assembly at a desired location on thetendon and pounding the bone punch through the tendon into the bone adesired depth at least passing through a cortical shell of the bone,wherein pounding the bone punch into the bone advances the nub portionthrough the tendon and into the bone; retracting the bone punch whilemaintaining the nub portion in registration with the formed hole in thebone; inserting a toggle-type suture anchor in the proximal portion ofthe anchor delivery tube, the toggle-type suture anchor having agenerally elongate body with at least a proximal and a distal end, witha length of suture extending through the elongate body; re-inserting thebone punch assembly into the lumen of the anchor delivery tube andpushing the toggle-type suture anchor through the bone hole at leastbeyond a cortical shell of the bone; retracting the bone punch in thelumen of the anchor delivery tube while also retracting the nub into theouter tube; and pulling the suture to toggle the toggle-type sutureanchor by drawing the distal end thereof toward the inside surface ofthe cortical shell of the bone.

Additionally or alternatively, the bone punch is inserted into the boneto a depth where a distal end of the outer tube is in contact with thetendon surface. Additionally or alternatively, the delivery device isconfigured such that, when the bone punch is advanced to a maximumextent relative to the outer tube distal end, the bone punch extendsbeyond the outer tube distal end a distance of greater than or equal toabout 20 mm. Additionally or alternatively, the delivery tube isconfigured such that, when the nub portion is advanced to a maximumextent relative to the outer tube distal end, the nub portion extendsbeyond the outer tube distal end a distance of about 6 to about 10 mm.Additionally or alternatively, the toggle-type suture anchor has aproximal end having a dimple configured to receive the bone punch and anangled distal end which, during the step of pushing the toggle typesuture anchor into the bone, enters the bone first, wherein the angleddistal end initiates toggling of the toggle-type suture anchor.

Additionally or alternatively, the toggle-type suture anchor comprisesproximal and distal suture passing bores with the suture passing througheach of the proximal and distal suture passing bores, and during thestep of pulling the suture, a portion of the suture projecting from thedistal suture passing bore is tensioned to toggle and position theanchor.

Additionally or alternatively, the delivery device further comprises aslot and a plunger; and the step of inserting a toggle-type sutureanchor in the proximal portion of the anchor delivery tube comprises:placing a cartridge carrying the toggle-type suture anchor in the slot;and depressing the plunger to move the toggle-type suture anchor fromthe cartridge to a position in alignment with a central axis of theanchor delivery tube lumen.

Another illustrative and non-limiting example takes the form of a methodfor transtendinous implantation of a toggle-type suture anchor in bone,the method comprising the steps of: positioning a delivery device over atendon and bone at a desired location, the delivery device including ahandle assembly having an outer tube affixed thereto and extendingdistally therefrom with a lumen therethrough, further with an anchordelivery tube extending through the lumen of the outer tube having aproximal end affixed to the handle assembly and distal end with a nubportion, the anchor delivery tube extendible and retractable relative tothe outer tube such that the nub portion is extendible and retractablerelative to the distal end of the outer tube, the delivery device alsohaving a bone punch assembly extending through the lumen of the anchordelivery tube and the nub portion with a pointed distal end and aproximal end extending past the proximal end of the delivery device;placing the anchor delivery tube, nub portion and distal end of thedelivery device bone punch assembly at a desired location on thepositioned tendon and pounding the bone punch through the tendon intothe bone a desired depth at least passing through a cortical shell ofthe bone, thereby also causing the nub portion to extend from the distalend of the outer tube, through the tendon and into the bone; retractingthe bone punch while maintaining the anchor delivery tube and nubportion in place, with the nub portion providing registration with theformed hole in the bone; placing a toggle-type suture anchor in theproximal portion of the anchor delivery tube, the toggle-type sutureanchor having a length of about 6 mm to about 10 mm defined by a maximumcross-sectional diameter of less than about 3 mm, the toggle-type sutureanchor including a bore through the cross-sectional diameter from a topsurface to a bottom surface and having a flossing working suturetherethrough, the toggle-type suture anchor having an angled distal endsurface which projects further longitudinally adjacent the top surface;re-inserting the bone punch into the lumen of the anchor delivery tubeand pushing the toggle-type suture anchor into the bone beyond thecortical shell such that the angled distal end surface starts to turnthe toggle-type suture anchor; retracting the bone punch and nub portioninto the outer tube; and pulling the working suture to complete thetoggling of the toggle-type suture anchor toward the inside surface ofthe cortical shell of the bone.

Additionally or alternatively, the bone punch is inserted into the boneto a depth where a distal end of the outer tube is in contact with thetendon surface. Additionally or alternatively, the delivery device isconfigured such that, when the bone punch is advanced to a maximumextent relative to the outer tube distal end, the bone punch extendsbeyond the outer tube distal end a distance of greater than or equal toabout 20 mm. Additionally or alternatively, the delivery tube isconfigured such that, when the nub portion is advanced to a maximumextent relative to the outer tube distal end, the nub portion extendsbeyond the outer tube distal end a distance of about 6 to about 10 mm.

Additionally or alternatively to any of the preceding methods, anadditional step may include positioning the tendon over the bone at adesired position. The desired position when performing such positioningmay be an original footprint of the tendon on the bone. Furtherillustrative and non-limiting examples take the form of methods ofimplanting a toggle-type suture anchor, or series or array oftoggle-type suture anchors pre-strung together on a working suture,using any of the preceding delivery devices, as further discussed in thebelow Detailed Description.

This overview is intended to introduce the subject matter of the presentpatent application. It is not intended to provide an exclusive orexhaustive explanation. The detailed description is included to providefurther information about the present patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIGS. 1A-1C are perspective views of an example anchor delivery devicein several configurations;

FIGS. 1D-1F are close up views of the distal end of the anchor deliverydevice corresponding to FIGS. 1A-1C;

FIGS. 1G-1I are partial cut-away views of the anchor delivery device inseveral configurations;

FIGS. 1J-1N are partial cut-away views illustrating the interaction ofinternal components of the anchor delivery device;

FIG. 1O is a partial cut-away view of the anchor delivery device inanother configuration;

FIGS. 1P and 1Q display features of an illustrative anchor deliverytube;

FIG. 1R illustrates coupling of the punch head;

FIGS. 2A-2E are various views of a representative toggle body;

FIGS. 2F-2G are views of alternative fin orientations in a toggle body;

FIG. 2H is partial cut-away view of a toggle body with a working sutureand locking suture in an open position illustrated;

FIG. 2I is partial cut-away view of the toggle body of FIG. 2H having aworking suture and locking suture in a closed position illustrated;

FIG. 2J is a schematic illustration of the interaction between thelocking suture and the working suture;

FIG. 2K is a schematic illustration of an alternative interactionbetween the locking suture and the working suture;

FIG. 3A is an illustration of a pre-threaded array of toggle typeanchors;

FIG. 3B is an alternative view of FIG. 3A showing the toggle anchors incross section to illustrate the threading route of the sutures;

FIGS. 4A-4D illustrate features of a plunger for securing cartridges tothe anchor delivery device;

FIGS. 5A-5D illustrate a cartridge for holding a toggle anchor;

FIG. 5E illustrates interaction of a cartridge of FIGS. 5A-5D with aplunger as in FIGS. 4A-4D;

FIGS. 5F-5H show transfer of a cartridge from a magazine to the deliverytool;

FIGS. 5I-5K show additional views of the magazine and cartridges; and

FIGS. 6A-6I illustrate the steps for implanting exemplary anchors of thecurrent invention and resulting pattern of continuous tensioned andlocked anchor to anchor single suture stitches.

DETAILED DESCRIPTION

The present invention includes multiple components, devices and methodsto create and use an overall system for reattaching soft tissue to bone.It is particularly useful to create a robust repair of torn tendons,such as the supraspinatus tendon, in an arthroscopic rotator cuffrepair. The implants and delivery devices make possible a faster, easierand lower failure rate anatomical repair. The tendon is securelyattached and held with adequate force to its original footprint withvery little creep during movement of the joint. This decreases apatient's time in a sling, increases the rate of healing reattachment oftendon to bone and allows early physical therapy to maintain range ofmotion and strength. The implanted array of anchors with a continuousset of anchor-to-anchor single suture stitches creates a seam-likeattachment akin to a sewing machine construct. Further, the smallcross-sectional size of the anchors (less than 3 mm in diameter) allowsthe anchors to be placed in close proximity to one another (less thanabout 7 mm between adjacent anchors). This creates an anchor to anchorsuture stitch. Combining this concept with the disclosed anchor designallows the suture stitch to be tightened and locked individually whenthe adjacent suture anchors are implanted. This can be repeated manytimes to implant a row of anchors with continuous independentlytensioned and locked stitches between adjacent anchors. Also, becausethe anchors are in a high-density array, the tension force components onthe tensioned suture are more vertically applied to the top surface ofthe tendon (or other connective tissue) to thereby hold the tendonagainst the footprint of the bone without creep or slippage during jointmovement.

One preferred anchor delivery device 300 for transtendinous implantationof individual anchors in an array is depicted in FIG. 1A. The deliverydevice 300 is particularly useful to implant anchors disclosed hereinand detailed below with respect to FIGS. 2A-2K and the disclosed arrayin FIGS. 3A-3B.

The high-density array of anchors is formed by implantation of theanchors in a chain or row which can be a relatively straight line orcurve depending upon the tear to be repaired at the discretion of thesurgeon. A delivery device system designed for sequential transtendinousimplantation of each anchor in the array is disclosed herein thatincludes three main components or assemblies: a delivery device thatincludes multi-function trigger and linkage features; a plurality ofcartridges with each cartridge retaining a suture anchor with theworking suturing running sequentially from cartridge to next cartridge;and, a magazine that is releasably mountable on the delivery device andhold the cartridges in order for sequential use.

FIGS. 1A-1C are perspective views of an example anchor delivery devicein several configurations, and FIGS. 1D-1F are close up views of thedistal end of the anchor delivery device corresponding to FIGS. 1A-1C.Starting with FIG. 1A, the delivery device 300 can be a gun-likecomponent that has a proximal housing 310 that includes a pistol griptype handle 311 and trigger 312 that moves from a spring retainedreleased position to an engaged position upon squeezing and holding thetrigger (as further illustrated below). The trigger 312 is linked tomoveable internal features within the proximal housing 310 to providedesired functions during implantation described below. The deliverydevice 300 includes an elongate tube 306 extending distally from theproximal housing 310. As shown in the close-up view of FIG. 1D, theelongate tube 306 includes a longitudinal slot 307 over its length forreceiving sutures therethrough as anchors are passed through the centrallumen of the tube.

FIG. 1A also shows that the proximal housing 310 is associated with abone punch having a distal punch head 322 and a proximal punch head 323.The proximal punch head 323 has a tapping surface 324 at its proximalside. Combined elements 322 and 323 form a punch head assembly. Asillustrated in FIG. 1D (which corresponds to the configuration of FIG.1A), the bone punch also includes a punch pin 320 having a tapered point321 adapted for probing through the tendon and/or grabbing the tendon toaid positioning. Positioning may include positioning the tendon in itsoriginal footprint, for tendons that are detached. In some examples,positioning as a separate step may be omitted or limited, such as whenrepairing a partial tear, such as a partial thickness articular sidetear or combination of full thickness and articular partial thicknesstears. A tendon can be considered positioned at a location for securingto bone either by virtue of having placed a fully torn or detachedtendon at a location, such as its original footprint, where it can bere-attached, or, with a partial tear, when the tendon is located where aphysician desired to have it when applying anchors to repair orotherwise address the partial tear.

The punch pin 320 and tip are configured for being pounded into bone tocreate a bone hole; the tapered point 321 is also used in some methodsdisclosed herein to engage and push against the proximal end of ananchor. The punch pin 320 extends through the proximal housing 310 andthe elongate tube 306. The punch pin 320 is affixed to the proximalpunch head 323 and is slidable within the distal punch head 322. Thedistal punch head 322 snap latches to the proximal housing 310 of thedelivery device. The proximal punch head 323 and distal punch head 322are connected by a spring-loaded mechanism that holds the punch pin 320in a fully extended position when the proximal punch head 323 is pushedagainst the distal punch head 322 and latched. When the proximal punchhead 323 is released from close connection with the distal punch head322, the spring loading causes the punch pin 320 to withdraw proximallyto a partially retracted position with only a short distal portion ofthe punch pin 320 extending beyond the elongate tube 306 for use inprobing a potential implant site. Such a configuration of the implanttool is shown in FIGS. 1A and 1D, where the punch pin 320 is the onlypiece extending from the distal tip of the elongate tube 306, the distalpunch head 322 is latched to the proximal housing 310, and the proximalpunch head 323 is not latched to the distal punch head 322. Alsoincluded on the proximal housing 310 is a receiver 398 for receiving aplatform configured to receive a magazine that carries cartridges whichhold individual anchors of the array to be implanted, as will beexplained below in association with FIGS. 5F-5K.

FIG. 1B and corresponding FIG. 1E show another configuration of thedelivery device 300. Starting with FIG. 1B, it can be seen that thetrigger 312 remains in a relaxed position and is not depressed(similarly to FIG. 1A). The proximal punch head 323 is now latched tothe distal punch head 322. Latching together of the punch head causesthe distal end of the punch pin 320 to extend further from the distalend of the elongate tube 306, as shown in FIG. 1E. Now an additionalelement can be seen, in that the elongate tube 306 has an anchordelivery tube 330 disposed therein. The action of latching together theproximal punch head 323 with the distal punch head 322 advances theanchor delivery tube 330 distally, and forces a distal portion of theanchor delivery tube 330 past the distal end of the elongate tube 306.The anchor delivery tube 330 also has a longitudinal slot 331 alignedwith the longitudinal slot 307 of the elongate tube for passing a suturetherethrough. With the anchor delivery device 300 configured as shown inFIGS. 1B and 1E, the device is ready for a surgeon to pound or tap thetapping surface 324, such as with a surgical mallet, to force the punchpin 320 and its tip 321 into bone to create a bone hole.

FIGS. 1C and 1F show a next configuration of the delivery device. Here,the distal punch head 322 is no longer engaged with the proximal housing310, and the proximal and distal punch heads 323, 322, are not latchedtogether. The disengagement of the distal punch head 322 and housing310, and disengagement of the proximal and distal punch heads 323, 322,is caused by actuation of the trigger 311, as further discussed below.As described in the method illustration of FIGS. 6A-6G, below, thisconfiguration would arise after a bone hole is created, and is used tointroduce an anchor/suture into the anchor delivery tube for implant. Tofacilitate such a step in the procedure, a portion of the anchordelivery tube 330 referred to as the nub 332 remains extended from thedistal end of the elongate tube 306, as shown by FIG. 1F. With the bonepunch retracted or removed, the anchor delivery tube 330 now defines anopen lumen 333 to allow an anchor to be introduced and passedtherethrough with the aid of the re-inserted bone punch, as detailedbelow. As also highlighted in FIG. 1F, optionally, the distal end of theelongate tube 306 may be tapered as shown at 308. The taper 308, in someexamples, provides the elongate tube 306 with a blunt distal tip thatcan be used to maintain force against the outside of a tendon duringmanipulation of an anchor and/or tensioning of a stitch between twoanchors.

At a high level, the procedure may be understood as follows. With theanchor delivery device 300 in the configuration shown in FIGS. 1A/1D,the physician may probe the surgical site to identify a location wherean anchor is to be implanted. Once the desired location is identified,the physician applies force to the tapping surface 324 of the bone punchto force the bone punch through the tendon and to create a bone holeusing the distal tip 321 of the punch pin 320. As the physician advancesthe bone punch in this manner, the proximal and distal punch heads 323,322 will become latched together to form the configuration as shown inFIGS. 1B/1E. The same action of advancing the bone punch relative to theelongate tube also advances the anchor delivery tube 330 and nub 332beyond the distal end of the elongate tube 306. Next, the trigger 311 isactuated to release the bone punch, pushing the bone punch in a proximaldirection to create the configuration as shown in FIGS. 1C/1F. Theimplant tool 300 is held in position, using the nub 332 to maintainregistration with the formed bone hole. In some examples, a portion ofthe nub will be inserted into the bone hole. An anchor is thenintroduced into the anchor delivery tube 330 and passed down the lumen333 thereof to the distal end, with force applied to advance the anchorusing the bone punch assembly. Complete insertion of the anchor can beconfirmed by maintaining pressure against the tendon to hold the nub 332in the desired registration relative to the bone hole, and pushing theproximal punch head 323 in the distal direction until the distal punchhead 322 latches with the proximal housing 310 and the proximal punchhead 323 latches with the distal punch head 322. Now the trigger 311will again be actuated, however, due to mechanisms that will beexplained below, this second actuation of the trigger after insertion ofthe anchor will apply positive retraction force, along with springforce, to retract the anchor delivery tube 330 and nub 332 into thedistal end of the elongate tube 306, as well as retracting the bonepunch. With the nub retracted, the physician can manipulate toggling ofthe anchor using the working suture without the nub 332 possiblydamaging the working suture, while force can be maintained against thetendon and bone by pressing the distal tip of the elongated tube 306against the tendon. After toggling the anchor, the delivery tool 300 ispulled back from the implant position and the suture lock is secured bypulling on the suture lock cord. If the anchor is the second or asubsequent anchor in a series, the physician may tighten the workingsuture to form a stitch while keeping pressure against the tendon withthe elongated tube 306 prior to moving the delivery device to a nextposition. The delivery device is then reset and the configuration ofFIG. 1A/1D is again assumed.

Turning now to the detailed mechanics of an illustrative example shownin the drawings, FIGS. 1G-1I are partial cut-away views of the anchordelivery device in several configurations. FIG. 1G generally correspondsto the configuration of FIGS. 1A/1D, in which the distal punch head 322is latched to the proximal housing 310, and the proximal punch head 323is not latched against the distal punch head, as can be confirmed in thedrawing by noting that punch head spring 325 is in an extended position.A nub coupler bar 355 is illustrated, and is pushed forward by theproximal punch head via proximal punch head pin 356, having a ridgethereon to interact with the nub coupler bar 355. The device contains aslide stop 350 and an ejector 352. The ejector 352 is in turn secured toa trigger coupler 313 that is pivotably attached at one end to thetrigger 312 and at its other end to the ejector 352. The ejector 352, atits own proximal end in the configuration shown, rests against thedistal punch head 322. The anchor delivery tube is connected at itsproximal end to a nub sub coupler 340 which is itself spring loaded bynub spring 343 relative to the proximal housing 310. As noted withrespect to FIG. 1D, in this configuration the anchor delivery tube nubis retracted into the elongate tube, meaning that the nub spring 343 isin a relaxed state, as shown.

FIG. 1H corresponds to the configuration of FIGS. 1B/1E, in which thedistal punch head 322 is latched to the proximal housing 310, and theproximal punch head 323 is now latched to the distal punch head 322, ascan be confirmed in the drawing by noting that punch head spring 325 isnow compressed. The same action of pushing the proximal punch head 323to latch with the distal punch head 322 also pushes the nub coupler bar355 distally, in turn pushing the nub sub coupler 340 and anchordelivery tube in a distal direction, compressing the nub spring 343 andadvancing the anchor delivery tube so that the nub extends from thedistal end of the elongate shaft, as shown by FIG. 1E. This movementalso changes the juxtaposition of the slide stop 350 and the nub subcoupler 340, which, as can be seen, are now positioned so that theproximal edge of the nub sub coupler 340 is distal of an upper portionof the slide stop 350.

FIG. 1I shows the use of the trigger 312 to force a change ofconfiguration from that of FIGS. 1B/1E to that of FIGS. 1C/1F. Here, thetrigger 312 is squeezed against the grip 311. The trigger coupler 313forces the ejector 352 to move proximally, overcoming the latch force ofthe proximal and distal punch heads 323, 322 relative to the housing 310and disengaging a latch coupling the proximal and distal punch heads323, 322 to each other (see FIG. 1R, below), forcing retraction of thebone punch. However, the nub 332 is not retracted into the elongate tube306 because the slide stop 350 engages with the nub sub coupler 340,blocking it from moving in the proximal direction. The nub spring 343stays compressed.

FIG. 1J shows in a closer view, taken from a rear angle as a partialcut-away view of the proximal housing. Here it can be seen that the nubsub coupler 340 abuts against the slide stop 350 at location 345. Theslide stop 350 is carried on a pin 357, to allow lateral movement aswill be further noted below. The pin 357 carries a slide stop spring 359that pushes the slide stop 350 laterally toward the position shown inFIG. 1J. An additional function of the slide stop 350 is illustrated inFIG. 1K, which provides another angle to view the partial cut-away (withthe slide stop spring 359 omitted). Here, the slide stop 350 includes anextension at 351 which is the part that will abut against the nub subcoupler 340 in the step shown in FIG. 1I/1J. Also visible is a ramp 353on the ejector 352 which will push against the extension 351 to preventan ejector hook 354 from engaging with a corresponding nub sub couplerhook 346 by pressing the ejector 352 down. As can be seen, the slidestop 350 in this configuration prevents retraction of the nub bylimiting the movement of the nub sub coupler 340 in the proximaldirection and also preventing engagement of the ejector hook 354 withthe nub sub coupler hook 346.

FIGS. 1L-1N are partial cut-away views further illustrating theinteraction of internal components of the anchor delivery device. FIG.1L illustrates decoupling of the slide stop 350 from the nub sub coupler340 and the ejector 352. A plunger control arm 385, which is inserted asshown below in FIGS. 4A-4D, pushes the slide stop laterally so that thenub sub coupler 340 cannot engage with the extension 351, and also movesthe slide stop along the pin 357 so that the ejector 352 no longerpresses against the extension 351 when moved in a proximal direction.The slide stop spring 359 is thus compressed, and remains so until thenub sub coupler 340 is again advanced when pounded to create the nextbone hole. In an alternative arrangement, decoupling of the slide stop350 from the nub sub coupler 340 may be achieved by having item 385coupled to a switch or lever on the housing, rather than using theplunger action, if desired. The position of the slide stop spring 359 isillustrative; other configurations and positions may be used.

The movement of the slide stop 350 allows a different interaction tooccur when the trigger is subsequently pulled, as highlighted in FIG.1M. Now, when the trigger is squeezed, the slide stop is no longerblocking movement of other parts, and so the slide stop is omitted fromthe view of FIG. 1M. The assembly remains extended until triggeractuation even with the slide stop moved laterally due to the latchingof the proximal and distal punch heads to one another and latching ofthe distal punch head to the proximal housing. Here, it can be seen thatthe proximal end of the nub sub coupler 340 is free to move proximally.Moreover, positive retraction force can be applied by the ejector 352when it is forced in the proximal direction by the trigger, because theejector hook 354 can now engage with the corresponding nub sub couplerhook 346. To ensure the hooks 346 and 354 interact, a ramp 358 on theunderside of the ejector 352 presses against the plunger control arm385. The resulting action is shown by the view in FIG. 1N, which showshow the nub sub coupler 340 moves past the slide stop 350, allowingretraction of the nub when desired, using force applied via the triggeractuation as well as force applied by the nub spring 343.

FIG. 1O is a partial cut-away view of the anchor delivery device duringa second actuation of the trigger. Here, the trigger 312 is squeezedagainst the grip 311, and the trigger bar 313 forces the ejector 352 ina proximal direction, unlatching the distal punch head 322 from theproximal housing 310. With the slide stop moved laterally out of theway, the nub sub coupler 340 is forced in a proximal direction as well,under the positive force applied by the trigger 311 via trigger bar 313,ejector 352, and hooks 354, 346 (FIG. 1M). By positive force, what ismeant is that more than the spring force is being applied, such as bythe mechanical linkage of the trigger 311, trigger bar 313, ejector 352and hooks 354, 346. In addition, the nub spring 343 also provides forceto move the nub proximally and will hold the nub in the retractedposition inside the elongate tube 306 until the nub is used again forplacement of another anchor.

FIGS. 1P and 1Q depict features of an illustrative anchor delivery tube.The anchor delivery tube 330, in this example, has a slot at 331 throughwhich sutures as well as the suture lock cord can pass during use. Aninner lumen is defined as shown at 333, through which anchors can pass,as well as the bone punch. If desired, the lower surface of the anchordelivery tube 330 may be stamped or otherwise formed with an indentationor internal trough or channel, as shown at 335, to accommodate a suture336 passing on the lower side of the anchor delivery tube 330. Suchstamping may not be necessary in some examples, depending on the size ofsutures used and how closely the features of the anchor and the anchordelivery tube lumen 333 line up. The proximal end of the anchor deliverytube may be formed with, or may have added thereto, additional materialshown at 337 for securing within the proximal housing 310.

In an alternative configuration, the anchor delivery tube may bereplaced by a push wire coupled to a relatively short nub portion havinga slotted cylindrical shape. The nub portion may have a length of 3-5centimeters, for example, such that a portion thereof can extend fromwithin the lumen of the elongate tube 306 without entirely exiting theelongate tube. The push wire can then extend up the elongate tube to theproximal housing, where it would then be physically coupled to the nubsub coupler 340. Thus a full-length anchor delivery tube may be replacedwith a shorter nub portion, if desired. The push wire (as well as theanchor delivery tube) may be pushed in the distal direction when thebone punch is advanced at the proximal end thereof (by including apusher or linkage attached to the push wire or the nub sub coupler forexample) if desired, or at the distal end thereof (by providing ashoulder for example toward the distal end of the bone punch to interactwith the nub and/or a short anchor delivery tube).

FIG. 1R illustrates coupling of the bone punch assembly. In FIG. 1R, theejector 352 is shown, including its proximal end having an angledsurface at 347. The angled surface at 347 is aligned with latch arm 348,which is itself part of the proximal punch head. The latch arm 348 isshown engaged with spring base 349, which is part of the distal punchhead, and carries the punch head spring 325. As can then be understood,as the trigger is depressed, the ejector 352 will move in a proximaldirection, engaging latch arm 348 and pushing the latch arm 348 outward,disengaging the latch arm 348 from the spring base 349, releasing theproximal punch head from the distal punch head. In some examples, thephysician may use this maneuver without causing the distal punch head todisengage from the housing, such as by lightly pulling the trigger,causing the proximal punch head to release from the distal punch headand thereby retracting the punch pin and pointed distal tip. As aresult, this feature allows the physician to readily control how far thedistal tip of the punch pin extends beyond the nub and/or the distal endof the outer tube of the anchor delivery device.

FIGS. 2A-2K are a series of illustrations of exemplary toggle bodies ortoggle-type anchors that can be used in a procedure for attaching tendonto bone. The illustrations also show a single working suture slidablydisposed in passages through the anchor and through a locking loop. Thelocking loop is configured to have an open position allowing movement ofthe single working suture, and a closed or locked position that preventsmovement of the single working suture.

Referring to FIG. 2A, a perspective view of a representative anchor inthe form of a toggle body 100 is illustrated. The toggle body 100 can bean elongate body 101 having a length defined by a proximal end 102 and adistal end 104. The elongate body 101 can be a generally cylindricalbody but other shapes are possible. For example, as shown in FIG. 2A,the toggle body 100 is generally cylindrical but the top surface 105 andbottom surface 107 have flat axially-extending surfaces that allow roomfor sutures when the toggle body 100 is in a round delivery tube. Thelength of the toggle body 100 is substantially longer than the diameterthereof, allowing the toggle body 100 to be inserted lengthwise oraxially into a small bone hole. Once inserted, unlike most anchors usedtoday, the entire body is pivoted or toggled so that it stays within thebone and has substantially its entire length compressed against materialinside the bone. That is, the longitudinal axis of the toggle body 100is rotated or pivoted from the direction used to insert through the bonehole, thereby preventing removal. This approach means that removal wouldrequire the anchor itself to fail, rather than simply being releasedfrom surrounding tissue, and provides high pullout strength (greaterthan 600 N before anchor failure when implanted in the array disclosedherein) from an anchor requiring a very small insertion hole (less thanabout 3 mm). As previously stated and described in detail below, smallinsertion holes allow much closer placement of anchors in a high-densityarray.

The toggle body 100, can have a length of about 6 mm to about 10 mm insome embodiments. This length gives adequate strength while leavingenough room inside the bone for the high number of anchors implanted.The toggle bodies are preferably molded or machined from a polymericmaterial, preferably a high tensile strength material such apoly-ether-ether ketone (PEEK) which is highly biocompatible. Inapplications where MRI imaging would not be an issue, metal can beutilized in part or all of the toggle body.

Referring now also to FIGS. 2B (top view) and 2C (bottom view), it canbe seen that the toggle body 100 can include a number of holes orpassages through the cross section of the toggle body 100. Asillustrated, the toggle body 100 has a proximal bore or passage 110, amiddle passage 108 and a distal passage 106. The passages 106, 108, 110extend from the top surface 105 to the bottom surface 107 such that thepassages 106, 108, 110 extend through the cross section of the elongatebody 101. In other embodiments, the toggle body may have fewer or morebores or passages, such as having a single bore, two bores, or more thanthree bores. In the illustrated embodiment, the proximal passage 110 anddistal passage 106 receive a portion of a common working suture slidablewith respect to the toggle body 100 during use. The middle passage 108receives a locking suture which is independent for each anchor used inan array of anchors.

The distal end 104 of the toggle body 100 has an angled surface. Asshown, the angled surface creates a longer upper longitudinal surface105 than lower longitudinal surface 107. In other words, the uppersurface projects a greater distance distally than the lower surface.This is useful during insertion of the toggle body 100 because theprojecting distal surface plows into cancellous spongy bone whenimplanted to initiate at least partial rotation of the toggle bodyduring insertion. Keeping in mind that the present toggle bodies 100 arepreferably implanted through the tendon, it is important that the togglebody 100 toggle every time or it may pull out of the bone hole undertension yet not be visible as it will be under the tendon.

The proximal end 102 of the toggle body 100 can include one or moreprojecting fins 112. The illustrated embodiment includes two fins 112.Each fin 112 projects outward and proximally. Further, in someembodiments, as depicted, the fins 112 project downward as they extendproximally. The function of the fins 112 is best understood withreference to FIGS. 2D and 2E which are distal and proximal end views ofthe toggle body 100, respectively. A reference circle 113 is includedwhich indicates the general maximum cross section or diameter of theelongate body 101. The bone hole in which the implant will be placed issized to closely match this dimension, as is the inner diameter of adelivery tube used to deliver the implant. In contrast, as shown, thefins 112 each project laterally beyond the outer cross section ordiameter of the elongate body. During insertion the fins 112 flex inwardunder compressive force due to contact with the inner diameter of adelivery tube to fit in the bone hole.

Once delivered and released from compressive forces of the deliverytube, the fins 112 relax to a size greater than the bone hole. In somepreferred embodiments, each fin tip extends about an additional 0.5 mmbeyond the size of the bone hole where that feature is inserted. Suchfin tips may also be described as extending about 0.5 mm beyond themaximum outer diameter of the rest of the anchor body, for example, inthe range of 0.4 mm to 0.7 mm. This feature provides an added safeguardagainst the toggle body 100 backing out of the bone hole under tensionif the toggle body 100 has not adequately toggled. Further, the fins 112are positioned so that tension on the toggle body 100 causes thepartially toggled anchor to grab cancellous bone and further rotate theanchor.

Alternative designs of the fins 112 are also depicted in FIGS. 2F and2G. The fins 112 in these figures have alternative positions on theelongate body 101 and direction of proximal extension. The fins 112 ofFIG. 2F are widest at a centrally located position to keep the anchorcentered in the delivery tube since the largest dimension is horizontalat the diameter of the tube during delivery. In some examples, the finsdo not provide the pullout strength necessary for the implanted anchorto reattach the tendon. As previously stated, in preferred examples,each anchor toggles so that the full length of the anchor is pressedagainst interior bone structure to provide adequate pull out strength.

The top and bottom views of FIGS. 2B and 2C show details of the proximal110, middle 108 and distal 106 passages. In particular, the middle holehas a platform 114 formed within the elongate body 101, part way throughthe cross section. That is, in this example, the middle passage 108 hasa change in size or shape partway along its length, to define a platform114. From the bottom view, it can be seen that the middle passage 108continues from the platform 114 with a slotted or oval shape or portion111, while having a circular profile from the top view. The function ofthese passages is detailed in the cross-section perspective views ofFIGS. 2H and 2I wherein representative cords or sutures 115, 116 havebeen pre-strung on the toggle body 100.

First, there is a single suture, called herein the working suture 115that extends into the proximal passage 110 from the top surface, andextends out at the bottom surface. The working suture 115 then extendsup through the distal passage 106 from the bottom surface and outthrough the top surface. This leaves a section 117 of the working suture115 extending past or adjacent the middle passage 108 along the bottomsurface. The working suture 115 can be flossed or is slidable throughthe distal 106 and proximal passage 110, meaning the toggle body 100 canslide on the working suture 115 when tension is applied. Second there isa locking loop 118 that encircles a portion of the section 117 of theworking suture 115 extending adjacent the outer surface of the togglebody 100 between the proximal 110 and distal 106 passages. The lockingloop 118 has a first open position as depicted in FIG. 2H wherein theworking suture 115 is free to slide through the locking loop 118 and asecond closed position depicted in FIG. 2I wherein the locking loop 118engages the section 117 and prevents it from sliding within the lockingloop 118.

Several examples refer to a suture, cord, or thread, which can be usedas the working suture 115 or in the locking loop 118. These elements maybe, for example, made of natural material such as silk and/or syntheticmaterials such as polyglycolic acid, polylactic acid, and polydioxanone,each of which are known for use as absorbable sutures, and/or nylon andpolypropylene, which are typically non-absorbable. Various coatings,including antimicrobial, anti-wicking or lubricious coatings may beapplied as well. More broadly, these elements 115, 118 may include anyitem that can be used to couple together objects in a surgicalenvironment, such as any sufficiently biocompatible metal, naturalmaterial, plastic or other artificial material adapted for use in asurgical procedure. Monofilaments or more complex structures includingbraids, weaves, windings, twisted threads, coated or multilayer member,etc. may be used.

In the embodiment depicted, the locking loop 118 extends from the bottomsurface of the toggle body 100 through the middle passage 108. Thelocking loop 118 includes a cord or suture having at least a slidableknot 120 tied therein to allow collapsing of the locking loop 118 when afree end or proximal end 121 of the suture lock 116 extending throughthe middle passage 108 is tensioned. As shown, the upper portion of themiddle passage 108 is sized to receive at least a portion of theslidable knot 120 therein. The slidable knot 120 then contacts thesurface of the platform 114 which does not allow the knot to passthrough towards the bottom opening. The lower oval portion 113 of themiddle passage 108 is a slot or oval which allows both legs of thelocking loop 118 to pass therethrough, preferable side by side in theslot direction. The interaction of these components locks the workingsuture 115 with respect to the toggle body 100.

As shown, especially seen in FIGS. 2C and 2I, the bottom of the togglebody 100 includes a channel 125 formed in the bottom surface 107 betweenthe proximal 110 and distal 106 passage. When the working suture 115 istensioned, it is pulled up into this channel 125 which is sized to makethe suture less able to floss or move therethrough by increasingfrictional resistance to such movement, but does not lock the suture.Further, the working suture then has two near 90-degree angle turns atthe bottom openings of the distal 106 and proximal 110 passage whichalso make it more difficult to floss, but do not lock the working suture115. The locking loop 118 closing around the working suture 115 andpulling it toward and at least partially into the slot or oval portion113 is the structure that locks the suture so that cumulative frictionprevents slippage of the working suture 115.

In the illustrative example shown in FIGS. 2H to 2K, the free end 121 ofthe suture lock 116 is configured to break away from the locking loop118 proximal of the sliding knot 120. A break knot is illustrated at 122and is one example of a way of introducing weakness in the suture lock.The break knot 122 is located a distance above the sliding knot 120,sufficient that when the suture lock 116 breaks away, the sliding knot120 remains intact and secure; for example, 3 to 10 mm proximal of thesliding knot, or more or less. Rather than a break knot 122, a nick orother point of weakness may be imparted at the desired or preferentialpoint of failure in the suture lock 116.

FIGS. 2J and 2K depict the way in which the locking loop 118 pulls thesection 117 of the working suture 115 into the oval portion 113 in twodifferent embodiments. The degree to which the section 117 of theworking suture 115 enters the slot 113 will be dependent upon how tightthe loop is closed, the size of the locking suture and the size of theslotted opening. In preferred embodiments, at least a portion of thecross section of the working suture 115 is pulled into the slot so thatthe edge surfaces of the slot walls provide significant friction and aidin locking. In another example, the preferential point of failure isdesigned to allow the locking loop 118 to be drawn into the slot beforethe failure occurs. The locking loop 118 in combination with the designof the middle passage 108 is an assembly for locking a slidable workingsuture 115 when tensioned in a suture toggle body 100 during tissuefixation to bone. The locking loop 118 encircles a portion of theworking suture 115, wherein collapsing the locking loop 118 compressesthe cross section of the working suture 115 to lock the working suture115 when tensioned. The suture lock 116 is preferably formed of a suturehaving at least a slidable knot 120 tied therein to form the loop 118 toallow collapsing of the loop 118 when a tightening leg 121 through thesecond passage 108 is tensioned. The second passage 108 has an upperportion for receiving the slidable knot 120 at least partially thereinthat terminates in a platform 114 within the toggle body 100 that doesnot allow passage of the slidable knot. The second passage includes alower portion having an oval shape for allowing both legs of the lockingloop to pass therethrough side by side and out the passage. Aparticularly preferred knot is a 4-throw uni knot. However, otherslidable knots 120 may be used, as desired. Further, the second passageoval portion is sized to allow movement of at least a portion of theworking suture 115 to be pulled therein in response to tension on thelocking cord. The working suture 115 is preferably a braided multistrandsuture having a compressible cross-sectional area that reduces by atleast about 25% when the locking loop is tightened during use. Theworking suture 115 can be a round and/or braided No. 2 suture in someembodiments. Other size and type sutures may be used.

As also shown in FIGS. 2I and 2K, after the sliding knot 120 istightened, and the working suture is drawn at least partly into theslot, the preferential point of failure in the locking loop 116 (such asthe break knot or nick described above) breaks, leaving free tail at 123on the locking loop, a distance above the sliding knot, while the restof the proximal portion of the suture lock 124 can be discarded. In someexamples, a more proximal portion of the suture lock is secured to acartridge, so that a physician may cause the suture lock to break asshown by pulling on the cartridge itself, as further described below. Inan example, the preferential point of failure is designed to allowtightening of the locking loop 118 onto the working suture 115 beforethe failure occurs. For example, the locking loop and the preferentialpoint of failure may be configured for breaking under a pull strength inthe range of 3-10 pounds of force, more preferably, 5-7 pounds of force,or more or less as desired. The pull strength needed to tighten thelocking loop 118 onto the working suture may be less than the pullstrength needed for breaking the preferential point of failure in someexamples by, for example, an amount in the range of 0.5 to 3 pounds, or0.75 to 2 pounds, or about 1 pound.

In some preferred embodiments, the above-described anchor does notfunction alone. Instead it is part of a pre-strung array of anchorshaving a common serially disposed working suture 115 therethrough. FIG.3A illustrates a pre-strung array 201. Each anchor 200 can be implantedsequentially within the array, then the working suture section extendingfrom the just implanted anchor to the just previously implanted anchorcan be tensioned, then locked at the just implanted anchor so that asuture stitch between the two anchors provides force against the tendonto hold it in place much like a single sewn stitch. With the array,multiple continuous stitches can be formed similar to a sewn seam.

In FIG. 3A a pre-strung array 201 of individual anchors 200 is depicted.The anchors 200 may be similar in form and function to the anchor 100described herein. The shown array has four anchors 200 as arepresentative chain. It is believed chains of 4 to 12 anchors would beuseful in tendon repair procedures such as rotator cuff repair. Oneparticular embodiment includes 8 anchors in an array. As depicted inFIG. 3A, the way in which the working suture 115 is pre-threaded throughthe series of anchors 200 is important to assure that they will toggleas desired and tension to form the stitch when the suture is tightened.The illustration shows the first anchor 202 to be implanted followed bythe second anchor 204, then the third anchor 206 and finally the fourthanchor 208. With this order of implantation understood, the workingsuture 115 has been pre-threaded down through the top of the proximalhole 210 and back up through the distal hole 211 of the first anchor202. The working suture 115 then continues to the second anchor 204where it is threaded down through the proximal hole 212 and back upthrough the distal hole 213 of the second anchor 204. The working suture115 then continues to the third anchor 206 where it enters the top ofthe proximal hole 214 and back up the distal hole 215 of the thirdanchor 206. The working suture then continues to the fourth anchor 208where it enters the top of the proximal hole 216 and passes up throughthe bottom of distal hole 217 of the fourth anchor 208. If the arraywere more than four anchors, the pre-threading would continue asdescribed for each subsequent anchor.

FIG. 3B is a cross sectional view of the array of FIG. 3A which moreclearly shows the threading of the working suture 115 within the anchors200 in the array 201. The way in which the locking suture 116 isdisposed in the middle passage is also shown for each anchor 200 asdescribed above with each locking loop 118 independent for each anchor.The locking suture 116 can have a preferential point of failure so thatit can be tightened then broken off above the slidable knot. This can beaccomplished by tying a break knot, or making a nick in, in the freetail of the locking loop just above the slidable knot, as furtherillustrated in FIGS. 2H to 2K, above. In some preferred embodiments theslidable knot is a 4-throw uni knot and the break knot is in the freetail just above the uni knot. The suture lock may be designed to breakat a desired tension with the slidable knot in place sufficient to lockthe working suture.

To create an implanted serial array of tensioned and independentlylocked anchor to anchor suture stitches for attaching a tendon to bone,a surgeon would begin with the pre-strung array 201 described in FIGS.3A and 3B. The first anchor 202 would be implanted through the tendoninto a formed bone hole and the working suture locked. The second anchor204 would then be implanted in close proximity to the first anchor 202,preferably less than 7 mm away. The second anchor is toggled and theworking suture tensioned at the same time by pulling on the workingsuture 115 that exits the distal hole 213 of the second anchor 204.Tension at this location not only toggles the second anchor 204 but alsotightens the working suture 115 going back to the first anchor 202 toform the tensioned stitch holding the tendon against the footprint. Thesecond anchor 204 is then locked so that the stitch remains tensionedand is isolated or independent of other stitches. The process isrepeated for the third anchor 206 and fourth anchor 208 or more. In onepreferred array, eight anchors are implanted and 7 tensioned and lockedstitches in a continuous row are formed. Further, in a rotator cuffrepair, multiple arrays can be implanted such as one array extendingacross the tendon in the medial portion of the footprint and a secondarray more lateral to the medial position.

FIGS. 4A-4D illustrate features of a plunger for delivering anchors fromindividual cartridges to the delivery device and a magazine for holdingcartridges on the anchor delivery device. Starting with FIG. 4A, thedelivery device is generally shown at 300 with the proximal housing at310. On one side of the proximal housing is a receiver 370 into which aplunger 380 can be slidably placed and retained. The top of the receiverincludes a slot 372 for receiving a cartridge 392 that carries an anchorto be implanted. The cartridge 392 can be seen to have at least firstand second ends of a working suture 393 extending therefrom.

The delivery device is shown relative to a patient 400 having a patientportal 402, which may be for example a shoulder portal that is formedfor performing arthroscopic surgery. In the example shown, the removedcartridge 392 is shown with the working suture 393 extending on eitherside thereof. The physician may pull the cartridge away from themagazine and the delivery device, as well as the portal 402, in order tofloss the working suture 393 so that an amount of slack is available oneither side of the anchor contained in the cartridge 392. The purpose ofthis maneuver is to ensure that as the anchor is advanced through thedelivery device and into the patient, there will be enough slack to makethis passage easy. That is, while it is possible to floss the suturethrough the anchor during delivery and implantation, it may bepreferable to generate slack before the implantation to make advancementof the anchor into position relatively easier. Once the anchor ispositioned, the extra slack can be taken out as the physician tensionsthe working suture to create a stitch between the anchor being toggledand a previously placed anchor.

Opposite the plunger 380 is a magazine 390 that can be releasablysecured to the proximal housing 310 and carrying a plurality ofcartridges 391. A cartridge ejector is shown at 394 for ejectingcartridges 391/392 one at a time. The magazine is shown with 7cartridges 391 therein, the 8^(th) cartridge 392 having already beenejected. In the example shown, at least one additional cartridge hasalready been ejected and used, since the working suture 393 can be seento extend into the elongate tube 306 and into the patient portal 402.

More details of the plunger and receiver are shown in FIGS. 4B and 4C.Starting with FIG. 4B, the plunger itself is shown at 380, in anextended position relative to a receiver 370. The slot 372 can beobserved in this top view of the proximal housing 310. When a cartridge(not shown) is placed in the slot 372, the plunger can be depressed asshown in FIG. 4C. Doing so laterally transfers the anchor from thecartridge into the bore through the length of the delivery device. Theanchor is then ready to be inserted by advancing the bone punch throughthe proximal housing and down the anchor delivery lumen. Referring backto FIG. 4B, the anchor is carried in a cartridge 392 such that when thecartridge 392 is inserted into slot 372, the anchor generally lies alongline 374, while the midline of the anchor delivery tube is showngenerally at 376. The plunger prepares the anchor for delivery bypushing the anchor laterally to the midline of the anchor delivery tubeat 376, and holds the anchor in position until the bone punch isadvanced to push the anchor down the anchor delivery tube.

In addition, the plunger being depressed causes the changes inconfiguration previously described within the proximal housing. Inparticular, in the illustrative example that is shown herein, depressingthe plunger moves the slide stop 350 discussed above laterally out ofthe way of the nub sub coupler 340 and out of the way of the ejector352, allowing the retraction of the nub after the anchor has beeninserted. In some examples, the anchor delivery device will not allowthe plunger to be actuated from its extended position to its depressedposition while the bone punch is extended down the lumen of the anchordelivery tube. That is, until the bone punch has been retracted after aphysician has first actuated the trigger, the plunger cannot bedepressed fully in some examples.

FIG. 4D shows the plunger in isolation. Here, the plunger 380 can beseen to include an anchor pusher 384 including an anchor platform 383that sits under the anchor, and matching bars 382 that extend intomatching slots of the cartridge. The plunger control arm 385 is alsoshown. The control arm 385 is the element discussed previously thatmoves the slide stop 350 laterally to allow retraction of the anchordelivery tube and nub after the anchor is fully implanted. The controlarm 385 also serves to push the ejector 352 upwards when in position toensure coupling of the ejector (and hence the trigger) to the nub subcoupler that in turn attaches to the anchor delivery tube and nub. Guidearms 381 are used to guide the plunger 380 as it slides in and out ofthe receiver 370.

Referring back to FIG. 1M, the plunger latch 386 (not visible in FIG.4D) is carried on the control arm 385. The plunger latch 386, when theplunger is fully inserted, rests against plunger catch 387 to preventremoval of the plunger 380. When the ejector 352 is used to pull backthe nub sub coupler 340, the bottom of the ejector 352 pushes thecontrol arm 385 in a proximal direction and, as shown in FIG. 1M, allowsthe plunger latch 386 to be released once the nub and bone punch havebeen at least initially retracted. The body of the plunger 380 mayconnect to the anchor pusher 384, in some examples, with a wave spring(not shown, but residing inside the body of the plunger 380) that allowsovertravel to ensure latching of the control arm 385 and plunger latch386. When the plunger latch 386 is released, the wave spring (or anotherspring, if provided) pushes the plunger back to its extended position.The slide stop may also move back to its original position under springpressure.

In an alternative configuration, the control arm 385 may not be part ofthe plunger, and may instead be coupled to a switch or lever on theproximal housing, allowing the physician to determine the mode oftrigger operation without using a plunger. To this end, item 399 in FIG.4A may be used as a switch or button to control position of the slidestop, for example.

In another alternative, the slot 372 may be placed directly in line withthe central axis 376 (FIG. 4B) of the anchor delivery tube, and ratherthan lateral movement out of the cartridge, an anchor may be placed inposition for advancement down the anchor delivery tube directly. As anexample, the slot 372 may instead be positioned at location 372A in FIG.4B, and the plunger 380 and receiver 370 could then be omitted. Forexample, a physician may remove a pre-strung anchor from sterilepackaging and directly place the anchor into a centrally positionedslot. Alternatively, a physician could place the anchor in a centralslot such as that at 372A by insertion of the cartridge. While someexamples herein show a cartridge configured for lateral removal of ananchor, in an alternative in which the cartridge is inserted in acentrally located slot (372A), a cartridge as shown in FIG. 5A/5B mayinstead have an opening as shown at 527 that allows removal of theanchor in an axial direction (such an arrangement may omit the boss 512and/or has the working suture positioned on top of the boss 512 to allowaxial movement). Other alternatives can be used as well.

To recap regarding the implantation procedure, the physician uses theconfiguration of FIG. 1A to probe the surgical site and identifies alocation at which an anchor is to be placed. The physician then taps orpounds on the proximal punch head which causes the bone punch toadvance. As the bone punch is advanced, the proximal punch head latcheswith the distal punch head, assuming the configuration of FIG. 1B, alsoforcing the nub distal of the distal end of the outer elongate tube. Asthe tapping force is applied, each of the bone punch pin and tip extendthrough the tendon and into bone, and the nub is pushed intoregistration with the bone hole, at least partly engaging the nub withthe bone hole. While this order of operations is useful in one example,the steps may be reordered as desired, such as by latching the punchhead together prior to probing, if desired.

The physician then pulls the trigger a first time. Because the plungeris not engaged/depressed at this time, the trigger actuation results inretraction of the bone punch, but not the nub at the end of the anchordelivery tube. A cartridge is taken from the magazine, extended out fromthe magazine to create slack on either side of the cartridge in theworking suture, and inserted into the slot for receiving cartridges onthe delivery device housing. Before or after cartridge placement, thebone punch is retracted to a position that places the distal tip of thebone punch proximal of the location of the plunger, allowing the plungerto now be depressed. With the cartridge in place and bone punchretracted, the plunger is used to push the anchor into alignment withthe anchor delivery tube. The bone punch is then advanced to push theanchor to and out of the distal tip of the anchor delivery tube. Fullextension of the bone punch is demonstrated by latching the proximalpunch head to the distal punch head, which is itself latched to theproximal housing of the delivery tool.

The physician will again squeeze the trigger. This second actuation ofthe trigger occurs with the plunger fully inserted, meaning thatactuation of the trigger retracts the bone punch as well as the anchordelivery tube, as the plunger insertion will have moved the slide stopout of the path of the nub sub coupler and forces engagement of theejector thereto, actively pulling the nub as well as the bone punch outof the bone hole. The same trigger action also releases the plunger asthe ejector pushes the control bar to release the plunger under springaction. What remains, as discussed in FIGS. 6A-6I, are the steps ofcompleting the toggling of the anchor and tensioning the working suture,followed by securing the suture lock, before moving on to the nextanchor. Though not shown, the anchor delivery tool may optionallyinclude a punch stop to prevent the bone punch from being removedentirely from the device.

FIGS. 5A-5D illustrate a cartridge for holding a toggle anchor. Startingwith FIG. 5A, a cartridge 500 is illustrated with a handle 502 adaptedfor grasping by the user/physician. An inner holder is shown at 510, andis surrounded by a cover 520. The inner holder 510 secures an anchor 100between an upper anchor support 511 and a boss 512. In the configurationshown in FIG. 5A, the cartridge is “closed” in that the anchor 100cannot be removed.

FIG. 5B shows the cover 520 raised to an “open” position in which theanchor 100 is no longer secured by the cover 520. The cover defines twochannels at 522, 524. First channel 522 provides a path for the workingsuture out of the cartridge 500, and second channel 524 provides a pathfor the suture lock, as will be further detailed below. The cover may bespring biased to the closed position, if desired, to prevent inadvertentremoval of the anchor 100 during handling. Alternatively, the cover caninclude detents to hold the cover in a closed position until pressure isapplied during insertion. In addition, the upper anchor support 511 andboss 512 are spaced so that the anchor 100 is held in position againstfalling out.

As noted previously, an alternative design may have the inner holder 510open in alignment with slot 527 to allow anchor removal in an axial,rather than lateral direction. For such an alternative, in an example,the upper anchor support 511 and boss 512 would be positioned higher upon the inner holder, such that the anchor 100 would be held at position516 as shown in FIG. 5B.

FIG. 5C shows the cartridge 500 in the closed position again with thecover down. The working suture 530 is now shown passing through firstchannel 522. The suture lock is shown as well, with the free end 540 ofthe suture lock passing through second channel 524 and the locking loopshown at 542. As can be seen, the boss 512 holds the working suture 530away from the underside of the anchor 510, making flossing of theworking suture easier prior to release of the anchor 510 from thecartridge. That is, because the bottom side of the anchor 510 mayinclude a channel that makes flossing of the working suture therethroughmore difficult, keeping the working suture 530 away from the bottom sideof the anchor 100 may make flossing easier. Also, when the workingsuture 530 is pulled close to the bottom side of the anchor 100, thepath that must be navigated when flossing includes first and second nearninety degree turns, increasing friction as the working suture 530 isflossed. Therefore, the boss 512 can be seen to make flossing easier insome examples. In other examples, the boss 512 may be designed so thatthe working suture does not wrap around it, and instead a simple supporton the bottom side of the anchor 100 may be provided, with the workingsuture then resting between the support and the bottom side of theanchor. It may also be noted that having the working suture placed asshown may aid in retaining the anchor in place until it is ejected bythe insertion of the plunger in the examples shown above.

FIG. 5D shows the back side of the cartridge 500. Of note here, the freeend 540 of the locking loop 542 passes into a channel and then to aspool 514. In an example, the free end 540 is attached to the spool 514,such as by a knot, so that the free end can be pulled a select distance(10 to 20 cm, for example) before reaching a point where it can nolonger unspool. When the physician seeks to use the locking loop, thecartridge 500 can be grasped and pulled until the spool runs out. Thephysician can then pull on the cartridge and therefore on the free endof the locking loop until the locking loop breaks at the break knot (orother preferential point of failure), as described below and above. Theresult is that the physician can manually grasp the cartridge to easilylock the locking loop and break the free end of the locking loop withoutneeding a special tool and/or without needing to attempt to grasp thethin cord of the free end of the locking loop. It can be observed thatthe spool 514 includes inner features 515 allowing a tool to be insertedand twisted to spool the free end 540 of the locking loop onto the spool514. As with the steps of toggling and/or tensioning a stitch, thedistal end of the anchor delivery tool may be used to apply exteriorpressure on the tendon as the locking loop is tightened and the free endis broken off.

FIG. 5E illustrates interaction of a cartridge of FIGS. 5A-5D with aplunger as in FIGS. 4A-4D. The rest of the proximal housing of theanchor delivery tool is omitted, but it may be understood that insertionof the cartridge 500 into the slot for receiving the cartridge has nowraised the cover 520 to an open position. The plunger is then slid intothe position shown. With the plunger depressed, the anchor pusherstructure 584 passes through the cartridge, with the anchor support 383and matching rails 382 passing through the cartridge. The rails 382 passon either side of the upper anchor supports 511, and ensure that theworking suture is released from the cartridge when the plunger isdepressed. As can also be seen, the control bar 385 is now inserted andperforms the functions of moving the slide stop discussed above.

FIGS. 5F-5H show transfer of a cartridge from a magazine to the deliverytool. Starting with FIG. 5F, the platform 550 is mounted on the receiver398 (FIG. 1A) of the proximal housing 310. In another example, platform550 may be a molded part of the proximal housing 310. A magazine 390 isshown ready for mounting on the platform 550, and carries a plurality ofcartridges shown at 391/392. The cartridge ejector 394 is configured torelease cartridges 391/392 from the magazine 390 one at a time.

As shown in FIG. 5G, the cartridge ejector 394 is actuated in a distaldirection to push cartridge 392 free of the magazine 390, whichcontinues to hold the remaining cartridges 391. The physician thenplaces cartridge 392 into the slot 372. It may also be noted that thecartridge ejector 394 remains in its distal position, preventing theremaining cartridges 391 from sliding over until the cartridge ejector394 is again actuated. FIG. 5H shows the cartridge 392 placed in theslot 372. In FIG. 5H, the plunger 380 has been depressed, which readiesthe anchor for implantation into the prepared bone hole. It may be notedthat FIGS. 5F-5H omit the working suture, which is shown in FIG. 4A.

FIGS. 5I-5K show additional views of the magazine and cartridges. InFIG. 5I, the magazine 390 is shown from its distal side, illustratinghow the cartridge ejector 394 tilts a cartridge 392 for ready removal bythe physician. To limit pressure on the cartridges during storage, astorage lock 552 may be included. That is, a spring is used to applylateral pressure on the cartridges 391/392 when in use; during storage,the spring is controlled by storage lock 552 to prevent pressure fromdamaging the cartridges 391/392. The storage lock 552 is optional.

FIG. 5J shows a closer view of the cartridge ejector 394. The cartridgeejector 394 is biased in the raised position shown in FIG. 5J by spring554. Doing so prevents the next cartridge in the magazine from beingloaded onto the cartridge ejector 394 until positively actuated by thephysician. In addition, by preventing the next cartridge from slidinginto position to be ejected until actively depressed, the cartridgeejector 394 prevents the next cartridge from being accidentally removedas the working suture is tensioned during the implantation procedure. Asshown by FIG. 5K, when the physician depresses the cartridge ejector394, the spring 554 is compressed and the cartridges 391 are forced toslide over, preparing the next cartridge 391 to be ejected.

It should be noted that the illustrative anchor implantation systemshown is but one example of how the presently disclosed anchor systemmay be implanted. For example, a system that fully withdraws the distalend of the bone punch back to the proximal housing as shown may not benecessary. Separate cartridges for each bone anchor are illustrated inthe implantation system; in other examples, several anchors may bedisposed together in one cartridge in a longitudinal fashion, forexample, for sequential loading. Another anchor delivery tool isdisclosed, for example, in U.S. Provisional Patent Application Ser. No.63/172,629, filed Apr. 8, 2021 and titled DELIVERY DEVICE FOR IMPLANTINGKNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFTTISSUE TO BONE, the disclosure of which is incorporated herein byreference. Rather than lateral release of an anchor from a cartridge, anaxial release may be used. In some examples, a cartridge can be omittedentirely. Any suitable implantation system may be used, as desired.

In FIGS. 6A through 6G, an exemplary method for implanting individualand an array of anchors is depicted. Further, FIGS. 6H and 6I illustrateexample suture stitch arrays as implanted on the surface of a rotatorcuff tendon having anchor to anchor continuous stitches that areindependently tensioned and locked that can result from using thismethod.

Referring first to FIG. 6A, a schematic of select parts of the shoulderrotator cuff 600 is depicted in order to explain the methods ofimplantation. The illustration includes a portion of the humeral head602 shown including an outer cortical shell layer 604 and an innercancellous bone material 606. A tendon, in this case the supraspinatustendon 608 is shown overlaying a portion of the humeral head where isattached to the footprint. The method is a transtendinous or through thetendon repair. The tendon 608 is first positioned in a desired locationfor reattachment to bone in the footprint of original attachment. Thedelivery device of FIGS. 1A-1R, or similar is then utilized to implantthe toggle type suture anchor through the tendon 608. To begin thedelivery device is set as in FIG. 1C with the distal nub 332 extendingfrom the distal end of the implant delivery tube 330 and elongate tube306. The bone punch 320 is fully inserted distally so that it extendsbeyond the distal end of the nub 332 and is locked in place, as is thenub locked in place. The device as configured is positioned on thetendon at the desired anchor placement and pounded in until the distalend of the outer tubular member is in contact with the tendon as shownin FIG. 6A. At this point the nub 332 extends through at least a portionof the cortical shell 604 (in thinner bone the nub 332 can extend intothe cancellous bone 606) and the distal end of the bone punch 320extends deeper into the cancellous bone 606. To achieve the desireddepth of implantation to assure toggling, the bone punch extends beyondthe elongate tube 306 distal end a distance of greater than or equal toabout 20 mm. Further, to assure nub registration with the bone hole, thenub portion 332 extends beyond the elongate tube 306 distal end adistance of about 6 to about 10 mm.

As depicted in FIG. 6B, the bone punch 320 is then retracted whilemaintaining the elongate tube 306 and nub portion 332 in place, with thenub portion 332 providing registration with the formed hole in the bone.Absent such registration with the bone hole by the nub portion 332, thelocation under the tendon would be lost and it would be very difficultto feed an anchor through the tendon which would tend to fill the holethrough which the bone punch traveled. In some examples, as describedabove, this step of the method may be performed by depressing a triggeron an implant tool where the implant tool is configured to maintain thenub portion 332 extended under certain circumstances (for example, withthe slide stop in place) while applying a positive retraction force tothe bone punch 320.

The first toggle type anchor is transferred or inserted into theproximal portion of the anchor delivery tube inside the elongate tube306. As shown in FIG. 6C, the bone punch 320 is then reinserted into thelumen of the anchor delivery tube and advanced distally. As shown inFIG. 6C, the toggle body 100 of the anchor is pushed out the distal endby the bone punch 320. The bone punch 320 continues to be advanced inthe distal direction to its original depth to push the toggle body 100into the bone. It has been found that pushing the proximal end of theanchor deep into the bone with the toggle body 100 having an angleddistal end causes or at least initiates rotation of the toggle body 100.This initial rotation assures continued rotation upon pulling tension onthe working suture 115 outside the body.

As shown in FIG. 6E, the bone punch 320 and nub 332 are then retractedby the application of positive force by the trigger (as shown inexamples above), as well as with spring action. This assures the nub 332does not cut or fray the working suture. The bone hole remains shown inthe drawings. The distal portion of the working suture extending fromthe distal passage is then pulled to complete the toggling of the anchoras aided by the proximal fins on the toggle body. This is shown in FIG.6E. With continued tension on the working suture, the toggle body 100 ispulled toward the inside surface of the cortical shell of the bone asshown in FIG. 6F. To aid this step, the anchor delivery tool distal endmay be pressed against the tendon to provide a counterforce againstpullout during toggling and/or suture tensioning; that is, as the anchoris toggled and the suture is tensioned, the toggle body 100 may reachand press against the cortical shell. Additional counterforce can beapplied in particular in regions of thinner cortical shell, such at theedges or outside of a tear footprint, and/or between the greater andlesser tubricals of the humerus. As depicted in FIG. 6G, once theworking suture 115 is tensioned, the locking suture is tensioned toclose the locking loop 118 around the working suture 115 and fix theworking suture relative to the toggle body 100. In some examples, thelocking suture is broken during this step at the knot which is at orinside the central bore of the anchor 100, thus, FIG. 6G shows only theworking suture extending back into the elongate tube 306.

With implantation of the first anchor, the working suture 115 is simplylocked as it cannot be tensioned to form a stitch until the secondanchor is implant. In some examples, the first anchor in a chain ofanchors can be pre-locked for this purpose; in other examples thesurgeon will lock the first anchor suture lock at the time of implant.Therefore, in preferred methods, the second anchor is implantedrepeating the above steps, except to the extent that the suture lock isdifferently engaged. As the working suture is pulled to toggle theanchor, any loose working suture between the first and second anchors ispulled through to form the tensioned stitch. During suture tensioningthe distal end of the elongate tube 306 can be maintained against theouter surface of the tendon to prevent pullout or even possible bonefracture at the cortical shell. Once properly tensioned, the secondanchor is locked. These steps are repeated for the rest of the anchorsin an array.

As shown in FIGS. 6H and 6I, using the above method and device cancreate a row of continuous stitches that closely spaced, individuallytensioned and tightened. A preferred pattern includes a row of stitchesgenerally perpendicular to the direction of the tendon as shown in FIG.6H. In a rotator cuff repair these would all be placed in a medialportion of the original tendon footprint. In some preferred embodimentsa second row of anchors is also implanted, especially in a rotator cuffrepair. The second row is implanted laterally of the first row and caninclude a zig zag pattern to put some anchors in the lateral portion ofthe original footprint and other anchors lateral of the footprint tohold down edges of the torn tendon. Other configurations are alsopossible depending on the size and shape of the tear. For example, on asmall tear a single zig zag row of stitches could be used as shown inFIG. 6I. Anchors may also be placed to create stitches over attachedportions of the tendon to reinforce the margins/edges of fully orpartially torn tendons.

The preceding provides a relatively complete description of the anchoritself, pre-strung anchor arrays, suture lock, cartridge, magazine, andanchor delivery tool. A range of inventions are thus disclosed, and notall components or parts needs to be used together. For example, thedelivery tool may be configured to for use with other anchors,cartridges, magazines, etc. Likewise, the anchors may be used indifferent configurations with other working suture and suture lockarrangements, other cartridges, magazines and delivery tools. Thus theoverall combination shown can be modified in a variety of ways.

Additional features and alternative designs for various components,subassemblies and assemblies may be found in the following patentapplications, each of which is incorporated herein by reference:

U.S. Prov. Pat. App. No. 63/172,564, filed Apr. 8, 2021, titled KNOTLESSMICRO SUTURE ANCHORS AND ANCHOR ARRAYS FOR ANATOMICAL ATTACHMENT OF SOFTTISSUE TO BONE, and U.S. patent application Ser. No. 17/551,588, filedDec. 15, 2021, titled KNOTLESS MICRO SUTURE ANCHORS AND ANCHOR ARRAYSFOR ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,565, filed Apr. 8, 2021, titledTENSIONABLE AND LOCKABLE MICRO SUTURE ANCHORS AND ANCHOR ARRAYS FORANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. patentapplication Ser. No. 17/551,709, filed Dec. 15, 2021, titled TENSIONABLEAND LOCKABLE MICRO SUTURE ANCHORS AND ANCHOR ARRAYS FOR ANATOMICALATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,613, filed Apr. 8, 2021, titled KNOTLESSMICRO SUTURE ANCHOR ARRAY FOR HIGH DENSITY ANATOMICAL ATTACHMENT OF SOFTTISSUE TO BONE, and U.S. patent application Ser. No. 17/551,728, filedDec. 15, 2021, titled KNOTLESS MICRO SUTURE ANCHOR ARRAY FOR HIGHDENSITY ANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,614, filed Apr. 8, 2021, titled METHODFOR CREATING A TENSIONABLE AND LOCKABLE SUTURE ANCHOR ARRAY FORANATOMICAL ATTACHMENT OF SOFT TISSUE TO BONE, and U.S. patentapplication Ser. No. 17/551,779, filed Dec. 15, 2021, titled METHOD FORCREATING A TENSIONABLE AND LOCKABLE SUTURE ANCHOR ARRAY FOR ANATOMICALATTACHMENT OF SOFT TISSUE TO BONE.

U.S. Prov. Pat. App. No. 63/172,629, filed Apr. 8, 2021, titled DELIVERYDEVICE FOR IMPLANTING KNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYSFOR ATTACHMENT OF SOFT TISSUE TO BONE, U.S. Prov. Pat. App. No.63/281,411, filed Nov. 19, 2021, titled DELIVERY DEVICE FOR IMPLANTINGKNOTLESS MICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFTTISSUE TO BONE, and U.S. patent application Ser. No. 17/551,811, filedDec. 15, 2021, titled DELIVERY DEVICE FOR IMPLANTING KNOTLESSMICRO-SUTURE ANCHORS AND ANCHOR ARRAYS FOR ATTACHMENT OF SOFT TISSUE TOBONE.

U.S. Prov. Pat. App. No. 63/172,624, filed Apr. 8, 2021, titledCARTRIDGE DEVICE FOR SUTURE ANCHOR AND SUTURE MANAGEMENT DURINGIMPLANTATION OF A MICRO SUTURE ANCHOR ARRAY, and U.S. patent applicationSer. No. 17/551,838, filed Dec. 15, 2021, titled CARTRIDGE DEVICE FORSUTURE ANCHOR AND SUTURE MANAGEMENT DURING IMPLANTATION OF A MICROSUTURE ANCHOR ARRAY.

U.S. Prov. Pat. App. No. 63/172,568, filed Apr. 8, 2021, titled LOCKINGSUTURE CONSTRUCT FOR TENSIONED SUTURE TO SUTURE BRIDGES IN ANCHOR ARRAYSFOR ATTACHING SOFT TISSUE TO BONE and U.S. patent application Ser. No.17/551,860, filed Dec. 15, 2021, titled LOCKING SUTURE CONSTRUCT FORTENSIONED SUTURE TO SUTURE STITCHES IN ANCHOR ARRAYS FOR ATTACHING SOFTTISSUE TO BONE.

Each of these non-limiting examples can stand on its own or can becombined in various permutations or combinations with one or more of theother examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments. These embodimentsare also referred to herein as “examples.” Such examples can includeelements in addition to those shown or described. However, the presentinventors also contemplate examples in which only those elements shownor described are provided. Moreover, the present inventors alsocontemplate examples using any combination or permutation of thoseelements shown or described (or one or more aspects thereof), eitherwith respect to a particular example (or one or more aspects thereof),or with respect to other examples (or one or more aspects thereof) shownor described herein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols. In this document, the terms “a” or “an” are used, as is commonin patent documents, to include one or more than one, independent of anyother instances or usages of “at least one” or “one or more.” Moreover,in the claims, the terms “first,” “second,” and “third,” etc. are usedmerely as labels, and are not intended to impose numerical requirementson their objects.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims.

Also, in the above Detailed Description, various features may be groupedtogether to streamline the disclosure. This should not be interpreted asintending that an unclaimed disclosed feature is essential to any claim.Rather, innovative subject matter may lie in less than all features of aparticular disclosed embodiment. Thus, the following claims are herebyincorporated into the Detailed Description as examples or embodiments,with each claim standing on its own as a separate embodiment, and it iscontemplated that such embodiments can be combined with each other invarious combinations or permutations. The scope of the protection shouldbe determined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

What is claimed is:
 1. A method for transtendinous implantation of a toggle-type suture anchor in bone, the method comprising the steps of: positioning a delivery device relative to a tendon, the tendon being located at a desired location for securing to bone, the delivery device including an anchor delivery tube having a lumen therethrough, the anchor delivery tube having a nub portion at a distal end thereof, wherein a bone punch assembly extends through the lumen of the anchor delivery tube and the nub portion with a pointed distal end terminating a distance distal of the distal end of the nub portion; placing the delivery device and bone punch assembly at a desired location on the tendon and pounding the bone punch through the tendon into the bone a desired depth, at least passing through a cortical shell of the bone, wherein the nub portion advances through the tendon and into the bone as the bone punch is pounded through the tendon and into the bone; retracting the bone punch assembly while maintaining the nub portion in registration with the formed hole in the bone and through the tendon; inserting a toggle-type suture anchor in the proximal portion of the anchor delivery tube, the toggle-type suture anchor having a generally elongate body having a length of suture extending through the elongate body from a top surface to a bottom surface thereof; re-inserting the bone punch assembly into the lumen of the anchor delivery tube and thereby pushing the toggle-type suture anchor into the bone beyond the cortical shell; retracting the bone punch and nub at least into the delivery device; and pulling the suture to complete toggling of the toggle-type suture anchor toward the inside surface of the cortical shell of the bone.
 2. The method of claim 1, wherein the delivery device further comprises an outer tube surrounding the anchor delivery tube over its length, wherein the anchor delivery tube is moveable relative to the anchor delivery tube; and the step of pulling the suture is performed with the outer tube pressed against the tendon at the desired location and with the nub retracted into the outer tube.
 3. The method of claim 2, wherein the delivery device comprises a proximal housing having a trigger thereon, and the step of retracting the bone punch and nub portion at least into the delivery device is performed by depressing a trigger to apply an active force to retract each of the bone punch and the anchor delivery tube and nub portion.
 4. The method of claim 2, wherein the bone punch is inserted into the bone to a depth where a distal end of the outer tube is in contact with the tendon surface.
 5. The method of claim 4, wherein the delivery device is configured such that, when the bone punch is advanced to a maximum extent relative to the outer tube distal end, the bone punch extends beyond the outer tube distal end a distance of greater than or equal to about 20 mm.
 6. The method of claim 4, wherein the anchor delivery tube is configured such that, when the nub portion is advanced to a maximum extent relative to the outer tube distal end, the nub portion extends beyond the outer tube distal end a distance of about 6 to about 10 mm.
 7. The method of claim 1, wherein the toggle-type suture anchor has a proximal end having a dimple configured to receive the bone punch and an angled distal end which, during the step of pushing the toggle type suture anchor into the bone, enters the bone first, wherein the angled distal end initiates toggling of the toggle-type suture anchor.
 8. The method of claim 7, wherein the toggle-type suture anchor comprises proximal and distal suture passing bores with the suture passing through each of the proximal and distal suture passing bores, and during the step of pulling the suture, a portion of the suture projecting from the distal suture passing bore is tensioned to toggle and position the toggle-type suture anchor.
 9. The method of claim 1, wherein: the delivery device further comprises a slot and a plunger; and the step of inserting a toggle-type suture anchor in the proximal portion of the anchor delivery tube comprises: placing a cartridge carrying the toggle-type suture anchor in the slot; and depressing the plunger to move the toggle-type suture anchor from the cartridge to a position in alignment with a central axis of the anchor delivery tube lumen.
 10. A method for transtendinous implantation of a toggle-type suture anchor in bone, the method comprising the steps of: positioning a delivery device over a tendon and bone, the delivery device including a handle assembly having an outer tube affixed thereto and extending distally therefrom with a lumen therethrough, further with an anchor delivery tube extending through the lumen of the outer tube having a proximal end affixed to the handle assembly, the anchor delivery tube having a nub portion at a distal end thereof, wherein the anchor delivery tube is extendible and retractable relative to the outer tube to allow the nub portion to extend and retract relative to the distal end of the outer tube, having a bone punch assembly extending through a lumen of the anchor delivery tube and the nub portion with a pointed distal end and a proximal end extending past the handle assembly of the delivery device; placing the distal end of the bone punch assembly at a desired location on the tendon and pounding the bone punch through the tendon into the bone a desired depth at least passing through a cortical shell of the bone, wherein pounding the bone punch into the bone advances the nub portion through the tendon and into the bone; retracting the bone punch while maintaining the nub portion in registration with the formed hole in the bone; inserting a toggle-type suture anchor in the proximal portion of the anchor delivery tube, the toggle-type suture anchor having a generally elongate body with at least a proximal and a distal end, with a length of suture extending through the elongate body; re-inserting the bone punch assembly into the lumen of the anchor delivery tube and pushing the toggle-type suture anchor through the bone hole at least beyond a cortical shell of the bone; retracting the bone punch in the lumen of the anchor delivery tube while also retracting the nub into the outer tube; and pulling the suture to toggle the toggle-type suture anchor by drawing the distal end thereof toward the inside surface of the cortical shell of the bone.
 11. The method of claim 10, wherein the bone punch is inserted into the bone to a depth where a distal end of the outer tube is in contact with the tendon surface.
 12. The method of claim 11, wherein the delivery device is configured such that, when the bone punch is advanced to a maximum extent relative to the outer tube distal end, the bone punch extends beyond the outer tube distal end a distance of greater than or equal to about 20 mm.
 13. The method of claim 12, wherein the delivery tube is configured such that, when the nub portion is advanced to a maximum extent relative to the outer tube distal end, the nub portion extends beyond the outer tube distal end a distance of about 6 to about 10 mm.
 14. The method of claim 13, wherein the toggle-type suture anchor has a proximal end having a dimple configured to receive the bone punch and an angled distal end which, during the step of pushing the toggle type suture anchor into the bone, enters the bone first, wherein the angled distal end initiates toggling of the toggle-type suture anchor.
 15. The method of claim 14 wherein the toggle-type suture anchor comprises proximal and distal suture passing bores with the suture passing through each of the proximal and distal suture passing bores, and during the step of pulling the suture, a portion of the suture projecting from the distal suture passing bore is tensioned to toggle and position the anchor.
 16. The method of claim 10, wherein: the delivery device further comprises a slot and a plunger; and the step of inserting a toggle-type suture anchor in the proximal portion of the anchor delivery tube comprises: placing a cartridge carrying the toggle-type suture anchor in the slot; and depressing the plunger to move the toggle-type suture anchor from the cartridge to a position in alignment with a central axis of the anchor delivery tube lumen.
 17. A method for transtendinous implantation of a toggle-type suture anchor in bone, the method comprising the steps of: positioning a delivery device over a tendon and bone at a desired location, the delivery device including a handle assembly having an outer tube affixed thereto and extending distally therefrom with a lumen therethrough, further with an anchor delivery tube extending through the lumen of the outer tube having a proximal end affixed to the handle assembly and distal end with a nub portion, the anchor delivery tube extendible and retractable relative to the outer tube such that the nub portion is extendible and retractable relative to the distal end of the outer tube, the delivery device also having a bone punch assembly extending through a lumen of the anchor delivery tube and the nub portion with a pointed distal end and a proximal end extending past the proximal end of the delivery device; placing the anchor delivery tube, nub portion and distal end of the delivery device bone punch assembly at a desired location on the positioned tendon and pounding the bone punch through the tendon into the bone a desired depth at least passing through a cortical shell of the bone, thereby also causing the nub portion to extend from the distal end of the outer tube, through the tendon and into the bone; retracting the bone punch while maintaining the anchor delivery tube and nub portion in place, with the nub portion providing registration with the formed hole in the bone; placing a toggle-type suture anchor in the proximal portion of the anchor delivery tube, the toggle-type suture anchor having a length of about 6 mm to about 10 mm defined by a maximum cross-sectional diameter of less than about 3 mm, the toggle-type suture anchor including a bore through the cross-sectional diameter from a top surface to a bottom surface and having a flossing working suture therethrough, the toggle-type suture anchor having an angled distal end surface which projects further longitudinally adjacent the top surface; re-inserting the bone punch into the lumen of the anchor delivery tube and pushing the toggle-type suture anchor into the bone beyond the cortical shell such that the angled distal end surface starts to turn the toggle-type suture anchor; retracting the bone punch and nub portion into the outer tube; and pulling the working suture to complete the toggling of the toggle-type suture anchor toward the inside surface of the cortical shell of the bone.
 18. The method of claim 17, wherein the bone punch is inserted into the bone to a depth where a distal end of the outer tube is in contact with the tendon surface.
 19. The method of claim 18, wherein the delivery device is configured such that, when the bone punch is advanced to a maximum extent relative to the outer tube distal end, the bone punch extends beyond the outer tube distal end a distance of greater than or equal to about 20 mm.
 20. The method of claim 19, wherein the delivery tube is configured such that, when the nub portion is advanced to a maximum extent relative to the outer tube distal end, the nub portion extends beyond the outer tube distal end a distance of about 6 to about 10 mm. 